a Randstad company

Manager (Head a.I. - Manuf./OP/LdH, QA/QMS/QC, EHS, QMB, QP/FvP), Advisor&PM (Pharma, Bio, MedTech, CAPEX, FDA/GMP/GxP, USP/DSP/F&F, CQV, OpEx, MDR)

Profil
Top-Skills
Head of Quality/QMS/QA Compliance Officer cGMP/GMP/GDP/GxP and Auditor Leiter der Herstellung AMG/AMWHV Quality Oversight, cGMP compliance, Quality Process, Quality Systems, KVP, Excellence) QMS (GMP/GDP, 13485, designing, implementation, maintenance, KVP, SOP, harmonization, TQM) Operational Performance (Lean, QA Operations, Excellence, Right First Time, Shop Floor) Validation and Qualification (Processes, USP, DSP, DQ-PQ, SAT, FAT, Risk Management) Project Management (PMO, Designing, Tracking, Risk Budget Control, Proof in, Reporting) Risk Management ( Risk-based Aporoach, Risk Analyses, FMEA, HACCP, Risk Process) Training (Management, Professionals, Employees, Workshops, Events, Face to Face, Front) Manufacturing (aseptic Production, A-E, Packaging, Engineering, Planning, Supply Chain) Quality Assurance (BRR,Deviation, CAPA,, Validation, Qualification, QRB, QAA, etc) QA (Releases, BRR, QP, PQR, RM, Inspection, Validation, QAA, Compliance, etc) Products (Biologics, Vacinnes, Liquida, Solida, OTC,, Bulk, Combinations, MDR/IVDR, etc) Technique (aseptic Fill&Finish, Lyophilization, VI, CAD, USP, DSP, Batch, Combi, etc)
Verfügbar ab
18.11.2022
Aktuell verfügbar - Der Experte steht für neue Projektangebote zur Verfügung.
Verfügbar zu
100%
davon vor Ort
60%
Einsatzorte

PLZ-Gebiete
Länder
Ganz Deutschland, Österreich, Schweiz
Remote-Arbeit
möglich
Art des Profiles
Freiberufler / Selbstständiger
Der Experte ist als Einzelperson freiberuflich oder selbstständig tätig.

7 Monate

2021-12

2022-06

consulting and hands-on service

Senior Consultant/Subject Matter Expert Quality Control Drug Product.
Rolle
Senior Consultant/Subject Matter Expert Quality Control Drug Product.
Projektinhalte

consulting and hands-on service (i.a. construction aseptic APS, QC / MiBi QC DP, Visual Inspection, Kits, AQL, Analytic Methods, Training / Qualification, etc.)

Kunde
Lonza Visp

2021 - 2021: consulting


Rolle: Head of Operations a. I. (ca. 100 FTE) and Senior Consultant

Kunde: fill & finish, WuXi


Aufgaben:

consulting (i.a. QMS / Standards / strategy, new isolator, URS and qualifications DQ / QbD, f&f isolator / inspection line, etc., InflaRx: cGMP / GMP compliance, QA optimization, CMO auditing, establishing QP, etc.)


2020 - 2020: start-up & CAPEX project duty


Rolle: Head of Operations a. I. (20 FTE) and Senior Consultant fill & finish

Kunde: WuXi Biologics (CDMO, partner Astra Zeneca (MAH), Chemical Park Leverkusen, D)


Aufgaben:

lead start-up & CAPEX project: construction and ramp-up managing operations, DSP/aseptic/sterile manufacturing (A-E), fill & finish/lyophilization/ isolator & RABS systems, vials, media-fill strategy, release business, GAP, cGMP/GMP/GDP/21 CFR 210/211 compliance, CMC, products: vaccines, biologics, etc.


2019 - 2019: operation/production, packaging, engineering, technique, planning, storage


Rolle: Head of BU Manufacturing a. I. (180 FTE, budget, 3 shifts, Leiter der Herstellung (LdH) AMBHV, board member, BU

Kunde: Rotexmedica (MAH/CMO, Trittau, D)


Aufgaben:

lead commercial duty: managing manufacturing and operations, USP/DSP/aseptic/ sterile manufacturing (MSAT, A-E), fill & finish/RABS, ampule/injection/vials/ syrings, KPIs/RFT, release business/BRR, CAPEX project: rump up, combination line, media-fills, EHS/cGMP/GMP/GDP/GxP compliance, RA/CMC, MASAT, lean/shop floor/Risk management, products: biologics, anti-infectives, BTM, etc.


2018 - 2019: start-up & CAPEX project


Rolle: Head of / Team Lead Filling Solutions a. I. (ca. 40 FTE, 2 shifts) & Senior Consultant fill & finish/aseptic behavior

Kunde: Rentschler (RFS, CMO, Rankweil, A)


Aufgaben:

lead start-up & CAPEX project duty: construction and ramp-up managing fill & finish group, USP/DSP/aseptic/sterile manufacturing (A-E), fill & finish/lyophilization/RABS systems, vials, syrings, media-fill, release business, process validation, CMC, CAPEX project: (FDA) aseptic behavior, aseptic/sterile/biologics/API production, biotech-plants/equipment, implementation lean/shop floor management, batch bank, products: biologics, API, anti-infectives, vitamins, drugs, LM/peptides, etc.


2017 - 2018: CAPEX Production (fill & finish / aseptic manufacturing, visual inspection)


Rolle: Senior Consultant & Senior PM

Kunde: BioNTech (MAH), site Mainz (D)


Aufgaben:

lead CAPEX PM duty: USP/DSP/aseptic/sterile manufacturing (MSAT, A-D), MES process, fill & finish/RABS systems, vial-lines, media-fill, GAP analyses, rump up, construction visual inspection, Knapp qualification, cGMP/GMP/GDP/GxP compliance, biotech processes/equipment/reactor, PPQ, CMC, products: mRNA/RNA, LM/peptides, biologics, vaccines, oncology, etc.


2016 - 2017: QMS integration


Rolle: Head QMS/QMB, RP § 52a AMG, Compliance Officer (ca. 20 FTE) and Senior Consultant / Lead PM

Kunde: Alcon / Novartis (MAH), site (logistic/warehouse) Freiburg (D)


Aufgaben:

lead commercial & CAPEX PM duty: GAP analyses MDR/IVDR, construction QA, QMS integration ISO 13485/ 9001/MDR/IVDR/14971, site transfer pharma, release business, GMP/GDP compliance/21 CFR 820, lean management logistic/warehouse center, products: biologics, API, drugs, MD (Cl. I-III)/IVD, MDR/IVDR, chemicals, etc.


2016 - 2016: FDA readiness/remediation program


Rolle: Deputy Head of Production & Compliance Officer a. I. (160 FTE, 3 shifts, Leiter der Herstellung (LdH) AMG/AMBHV, operation/production (C-E), engineering, technique, planning, BRR, storage)

Kunde: Catalent (CDMO, Schorndorf, D)


Aufgaben:

lead commercial & PM duties: bulk manufacturing/plants/equipment, granulation/ extraction/coating systems, lead PM: FDA readiness/remediation program (PAI, preparation, etc.), KPI/RFT, BRR/releases, process safety, lean/shop floor management, product transfers, process validation, batch bank, cGMP/GMP/GDP compliance, deviations/CAPA/CC, products: APIs, drugs, tablets, capsules, etc.


2014 - 2015: accountable QMS and Q-standards/strategy


Rolle: Head of Quality/Corporate Quality a. I. (ca. 150 FTE, cost/budget management, board member, Head BU: corporate & site QUs/QAs, lead GQRB, global/all sites, QC/analytics/laboratories, QPs, pharma covigilance (PV), RM, accountable QMS, Audit & Training system)

Kunde: Acino Pharma (MAH/CDMO, Aesch, Liesberg, CH)


Aufgaben:

lead commercial & CAPEX PM duty: accountable QMS and Q-standards/strategy, cGMP/GMP/GxP compliance, PPQ, CTD/BLA, RA/CMC, quality on the floor, release/BRR/PQR management, RM/deviation/CAPA management, inspection/ customer audits, lead PM: FDA feasibility study, site risk assessment/ICH Q9, site transfer (products, plants/equipment, analytics), site decontamination (penicillin derivates), lean/shop floor management, QC lean lab, construction & organization corporate quality, products: API, drug, penicillin derivates, OTCs, implants, etc.


2013 - 2014: release qualifications / validations


Rolle: Senior Manager / QA Manager a. I. Pharma-/BioTech & delegated QP/FvP

Kunde: Roche (MAH, Basel, CH, Genentech, USA)


Aufgaben:

lead commercial & CAPEX PM duty: responsible cGMP/GMP/GDP/GxP compliance, SOP/Q-standards, release qualifications / validations (CQV, ECC, URS, DQ-PQ, processes, utilities, facilities, HVAC, SAT, FAT, CE, testing), deviation/CAPA management, fill & finish (A-E), FDA readiness program, QP releases/BRR, lead PM: turnaround & transfer clinical API to commercial, WBI/WFI/filling plants/ equipment, quality process management in USP/DSP/ MSAT, quality on the floor, implementation RM/FMEA, roducts: IMP, R&D, LM/Biologics/oncology, API/commercial, drugs (liquida/solida), etc.


2011 - 2013: cGMP/GMP compliance Manufacturing & QA


Rolle: Senior QA Manager a. I. & Senior Consultant

Kunde: Sandoz (MAH/CMO, Kundl, Schaftenau, Unterach, A)


Aufgaben:

lead commercial duty: QMS/SOP management, deviation/CAPA/change control and complaints management, quality on the floor, biotechnology/RABS systems, and USP/DSP (scale up) processes, fill & finish, bio/cell reactors, responsible cGMP/GMP/GDP compliance, CMC, SOP/Q-standards, RM/FMEA management, CAPEX PM duty: lead rollout SELS & training BUs/BURs, lead site training deviation/trackwise, lead project underfillings, lead transfers (biologics/products, biotechnology), FDA inspection: PAI / post, products: LM/Biologics/Biosimilars, penicillin derivates, oncology, API/commercial, drugs (liquida/solida), etc.


2011 - 2012: QP/FvP releases, QMS/SOP management


Rolle: Senior QA Manager a. I. & QP/FvP (ca. 10 FTE, Executive Manager)

Kunde: Janssen Cilag / J&J (MAH), site (logistic/warehouse) Freiburg, Baar (CH)


Aufgaben:

lead commercial duty: QP/FvP releases, QMS/SOP management, deviation/CAPA/change control and complaints management, PQR management & releases, quality on the floor, logistic / warehouse systems & processes, responsible cGMP/GMP/GDP compliance, RM management, lead CAPEX PM duty: site to site transfer pharma products, training / personal qualification, products: LM/biologics/biosimilars, vaccines / blood preparations, oncology, drugs (liquida/solida), implants, cytostatic, OTCs, API/commercial, drugs, etc.


2009 - 2010: EHS compliance / system and management


Rolle: Site Head EHS a. I. & Compliance Officer (ca. 8 FTE)

Kunde: Alstom (Neumark, D)


Aufgaben:

lead commercial duty: EHS release, EHS compliance / system and management (EHS media, SCC, ISO 14001 / EMAS), SCC management / surveillance, contractor / obligation management, EHS construction site management, EHS audits & trainings, site risk assessment, lead CAPEX PM duty: implementation and ramp-up internal EHS excellence road map, incident / emergency management, products: construction pharma / chemical / power plants & equipment, etc.


2001 - 2008: Manufacturing & Quality


Rolle: Industrial Expert/Independent SME, Senior Project Manager & Senior Advisor, Interim Manager, Lead Auditor

Kunde: Martinswerk (Bergheim, D), Mühlens/P&G (Köln, D), Hüttenes-Albertus (Düsseldorf, D), Johnson & Johnson (Düsseldorf, D), etc.


Aufgaben:

  • Manufacturing & Quality (cGMP/GMP/GDP, EHS & ISO regulations and compliance, site QMS, etc.), lead strategical PM: chemical / industrial parks Germany (Bayer/Leverkusen, Infraserve Höchst/Knapsack/Kalle Albert, Wesseling, Infracor Marl, Infraleuna, Chemiepark Bitterfeld & Skopau, etc.)
  • Senior Advisor REACH, MDD/IVD (Kl I-III) , ISO 13485, Quality Compliance & Only Representative, Fresenius (Schweinfurt, D), Jowat (Detmold D, Buchrain, CH), Ineos/Innovene (Dormagen, Marl, D), dalli/Grünenthal (Stolberg, Aachen, D), Membrana, (Wuppertal, D), etc
  • Quality Expert Recalls & Assessments, implementation QMS excellence (ISO 9001/EFQM), dalli / Grünenthal Pharma (Stolberg, D)
  • QEHS Manager & Site Representative (ca. 15 FTE, GMP, ISO 9001 / EMAS / 14001 / SCC, etc.), CWS (Düren, D)
  • REACH representative EU twinning projects and IHK, governments/enterprises, sites in Europe, USA, Asia, etc.
  • EHS expert & Senior Consultant EHS compliance / EHS management systems


1998 - 2004: Management System Board


Rolle: VCI Executive Referent and Senior Project Manager & Advisor, lead PM duty: i.a.


Aufgaben:

  • Lead Management System Board NRW (regulatory compliance and systems: QMS, cGMP/GMP, ISO 9001/13485, 14001/EMAS, ICH, inspections/audits, ca. SME leadership for 140 enterprises in NRW
  • Manufacturing & quality (cGMP/GMP, EHS & ISO regulations and compliance, site QMS, etc.), lead PM duty: cGMP/GMP site and plant management, approval (authority) management, crises management, obligation systems & 52a BImSchG, § 5 (1) Nr. 3 BImSchG, Seveso 2, expert VAwS plants, etc., VCI members


1993 - 1998: risk assessments


Rolle: Consultant, Lead Project Manager, Coacher, Trainer and Lead Auditor

Kunde: Dr. Adams und Partner


Aufgaben:

  • Turnaround Hoechst AG (i.a. site risk assessments, management transfer products/plants/equipment, filling lines / fermenter / A-E, products: API, biologics, drugs, etc., manufacturing & quality (cGMP/GMP compliance, EHS & ISO regulations and compliance), Hoechst/HMR/Aventis (Höchst/Mainz/Griesheim, D) Celanese (FFM, D), etc.
  • Implementation of Management & Legal Safety Systems (i.a. cGMP/GMP, QMS/ISO 9001, EHS regulations/EMAS/ISO 14001, Integrated Management system (IMS)), Hoechst (FFM, D), Bayer, Leverkusen (D), BP/EC Erdölchemie/OMW (Dormagen, Karlsruhe, D), Dr. Oetker (Budenheim, D), Deutsche Bahn (Berlin, Frankfurt, D), GEA (Stuttgart, D), etc.
  • Lead Auditing (ISO 9001, EHS Certifications), i.a. ASCA Program (ca. 120 enterprises & audits, FFM area), G+H Isover (Ludwigshafen, Berg.-Gladbach, D), LFK Lenkflugkörpersysteme (Friedrichshafen, D), etc.

Academical career:

1990 ? 1992:                    

Institution: University Cologne

Degree: Dissertation

 

1981 ? 1990:                     

Institution: University Cologne

Degree: Master Chemistry

 

1980 ? 1981:                        

Education: Military Service    

 

1971 ? 1980:                      

Institution: Städtisches Dreikönigsgymnasium, Cologne

Education: A Level

 

1967 ? 1971:                      

Institution: Katholische Grundschule Altonaer Strasse, Cologne

Qualifications:

2017 - 2017:

QMS training new ISO 13485 (TÜV)

2016 - 2016:

QA Oversight (Referent ECA Master Congress Wien)

2012 - 2012:

QP/Fachtechnisch verantwortliche Person (FvP), Konzept Heidelberg

 

2001 ? 2006:

member expert committee REACH, EU twinning projects (REACH).

1998 - 2006:

member steering committee, Dr. Adams Zertifizierung and EUROCERT

1998:

  • Member steering committee of certification companies, Dr. Adams und Partner and EUROCERT
  • DGQ Auditor
  • EOQ Quality Auditor, EOQ Quality Systems Manager
  • Fachauditor Chemie, Auditor, EOQ Auditor, DGQ Zertifikat QM, DGQ e.V.,

1997:

accredited EHS Auditor (ASCA, ISO 14001), TGA GmbH

 

1994:

GMP and Auditor training, Pharma Training Service

1993:

  • DGQ Fachauditor Chemie, DGQ Zertifikat QM
  • technical expert hazardous substances (§13 Abs.2 GefahrstoffV)
  • Fachauditor Chemie, Auditor, EOQ Auditor, DGQ Zertifikat QM, DGQ e.V.,

1990:

technical expert pressure vessel and pipeline § 32 DruckBehV, TÜV e.V.

Master Chemist

English professional (fluent) in words and writing
German native speaker

Top Skills
Head of Quality/QMS/QA Compliance Officer cGMP/GMP/GDP/GxP and Auditor Leiter der Herstellung AMG/AMWHV Quality Oversight, cGMP compliance, Quality Process, Quality Systems, KVP, Excellence) QMS (GMP/GDP, 13485, designing, implementation, maintenance, KVP, SOP, harmonization, TQM) Operational Performance (Lean, QA Operations, Excellence, Right First Time, Shop Floor) Validation and Qualification (Processes, USP, DSP, DQ-PQ, SAT, FAT, Risk Management) Project Management (PMO, Designing, Tracking, Risk Budget Control, Proof in, Reporting) Risk Management ( Risk-based Aporoach, Risk Analyses, FMEA, HACCP, Risk Process) Training (Management, Professionals, Employees, Workshops, Events, Face to Face, Front) Manufacturing (aseptic Production, A-E, Packaging, Engineering, Planning, Supply Chain) Quality Assurance (BRR,Deviation, CAPA,, Validation, Qualification, QRB, QAA, etc) QA (Releases, BRR, QP, PQR, RM, Inspection, Validation, QAA, Compliance, etc) Products (Biologics, Vacinnes, Liquida, Solida, OTC,, Bulk, Combinations, MDR/IVDR, etc) Technique (aseptic Fill&Finish, Lyophilization, VI, CAD, USP, DSP, Batch, Combi, etc)
Produkte / Standards / Erfahrungen / Methoden

Occupational career:

2015 - today:

Role: owner

Customer: On request


2004 - today

Role: Master Chemist, SME, Interim Manager, Head of Manufacturing, LdH AMG/AMWHV, Head of Quality, Site Head of EHS, Senior QA Manager, QMB, QP/FvP, RP 52a AMG, Senior Project Manager & Advisor, Lead Auditor, Trainer


Tasks:

SME: liquida sterile/aseptic (vials/injections/ampules/syrings, isolator/RABS/ lyophilization) and solida manufacturing (tablets, powder, capsules, coating), EHS, quality/QA/QC oversight, QP/FvP, risk management, (FDA) cGMP/GMP/GDP, MDR/IVDR/FDA compliance, CAPEX projects (construction operations, quality/QA/ corporate, launch, bring in the market, USP/DSP, scale ups/spin offs, transfers (products, technique), QMS/Quality strategy, lean/shop floor management, etc.


2009 ? 2015:

Role: Senior Executive Manager

Customer: ex.bros (2009-2010) / ex.bros swiss (2010)


2003 ? 2009:

Role: Entrepreneur, Advisor and Industrial Expert


1998 ? 2004:

Role: Excecutive Referent Assoziation

Customer: Chemical Industry e.V., Regional Assoziation NRW, Chemistry/Pharmaceutical Industry


1993 ? 1998:

Role: Senior Consultant, Senior Project Manager, Coacher, Trainer and Lead Auditor

Customer: Dr. Adams Unternehmensberatung GmbH/Zertifizierungs- und Umwelt-Gutachtergesellschaft mbH


1990 ? 1992:

Role: Deputy executive Director of institute (Head Production/QA/QC and Purchasing)

Customer: Inorganic Chemical Institute of the University Cologne


Key expertises (selection):

  • production/operations
    • selection of profund (interim) director, manager and consultant competences
  • quality and EHS
    • selection of profund (interim) director, manager and consultant competences


labour permit:

Switzerland and EU


key duties/responsibilities (Quality):

Head of Global Quality/Head of Corporate QA (member board, ca. 150 FTE), Quality Representative/Executive, Head Quality System/QMB, GMP Compliance Officer, QP/FvP, Senior QA Manager, Site Head EHS, Senior Risk Manager, SME, GxP Training Manager

  • lead quality strategies and corporate/site QU/QA/QC organizations
  • accountable QMS (i.a. implementation, set-ups, reviews, ICH Q10, GMP/EHS compliance, maintenance, SOP management/harmonization, DCM/eDMS, integrated systems/IMS, process/SIPOC management, QCP, process owner, KPI/KQIs/CIP process, internal and external / supplier auditing)
  • responsible Quality / GxP requirements and quality management (i.a. batch releases, SMF, recall management, assessments/GAP analyses, ICH Q10, cGMP/GDP, FDA/EU guidelines, ISO 13485, CMDCAS/MDSAP, CFR Part 820, ISO 9001, TS16949, CSR, EFQM/TQM, ISO 14001, EMAS, Q/EHS manual/standards, escalation management, trainings)
  • lead inspection readiness programs (i.a. FDA/PAI prgrams, EMA, Swissmedic, ANVISA, etc. PM Lead, QSIT programs, remediation, QA Oversight, FDA Compliance Check/GAP, 21 CFR 820, data control/integrity, QbD, PMDIs, risk-based-approach, excellence programs, FDA trainings, etc.)
  • quality assurance (i.a. release business, validation, VDM, QA oversight, PQR/AQR, complaint/deviation/CAPA management, TrackWise, change control, data matrices/data integrity, supplier management/CMO business/qualification, QAA/QSV, pharmacovigilance/PV)
  • transfer business (all transfer phases, carve outs, evaluation, project management/design, risk barriers/management, operationalization, closes, i.a. entity, sites, plants, product pipelines, production, galenics, brands, technique/ equipments, systems, processes, regional/Swiss/EU/US/ SA/Asia market, etc.)
  • qualification & validation (i.a. VPM URS, DQ-PQ(I/II), SAT, TAT, FAT, Q review, pharma technique,plants / equipments, utilities, facilities, liophylisator, HVAC, WBI/WFI, processes, mediafill)
  • risk management (i.a. site risk assessments, incident management, FDA risk based approach, risk strategy, GAP analyses, FMEA/HACCP, risk control, risk audit systems, ICH Q9, ISO 14971, EKAS, )
  • clinical studies and regulatory affairs (i.a. CMC, GCP, study phases I-IV, CDMR, REACH, regulatory strategy/management)
  • IT (i.a. MS Project, SAP, TrackWise, ERP, LIMS, e-learning, PMP, CAQ)
  • training (i.a. concepts/programs, management training, workshops)


key duties/responsibilities (Production/Operation):

Head of Production (i.a. §12 AMWHV, ca. 120 FTE) GxP Compliance Officer Site Head EHS

  • operation/production (i.a. aseptic/steril production, GMP readiness, PPS, cleaning rooms A-E/Annex 15, upstream /downstream processes, upstream organization, separation, exposure processes, isolations/isolators, processing of raw materials, granulation, extraction, wheiging, mixing, coating, fermentation, reactors, conti/batch systems, stirrer tanks, containment, Bio conversion, Bio katalyses, packaging, track & trace, logistic/distribution processes, trainings)
  • lead production readiness programs (i.a. FDA/PAI, production lead, remediation/PAI programs, FDA compliance /21 CFR 820, data control / integrity, risk-based-approach, lean / excellence programs, etc.)
  • strategy projects (i.a. awarness/mindset programs, Corporate/QA/QC/QM Organization, SWOT/5-box analyses, road maps, spin offs/due dilligence/M&As, turnarounds/transaction, buy-in/out, Best in Class, BPE/Excellence Programs, Six Sigma, change mangement/re-engineering, product portfolio/Spin offs, QA oversight, CMO management, Lean Management, Lean Production, Shop Floor Management, MCRS/ Reporting)
  • supply chain management (i.a. SCM/SCOR/SSCM, Sourcing - single/multi, procurement, allocations, indications, tools, life cycle, launch/bring in the market, R&D, supplier/vendor management)
  • lead EHS management (i.a. EHS system, directions, monitoring, analyses, safety management, hands-on, trainings


Key Competences:

  • Industrial Expert/SME, Manager, Head of Manufacturing, LdH AMG/AMWHV, Head of Quality, Site Head EHS, Senior QA Manager, Management Representative, QMB, 52a AMG, QP/FvP, Senior Project Manager, Senior Advisor, Lead Auditor, Trainer
  • SME:
    • liquida sterile/aseptic (vials/injections/ampules,syrings, isolator/RABS/ lyophilization) and solida manufacturing (tablets, powder, capsules, coating), quality/QA/QC oversight, QP/FvP, risk management, (FDA) cGMP/ GMP/GDP, MDR/IVDR, CAPEX projects (GAP, construction operations, quality/QA/ corporate, launch, bring in the market, USP/DSP, scale ups/spin offs, transfers (products, technique, sites), QMS/IMS/Quality strategy, lean/shop floor management, etc.
  • manager
    • interim manager (operations, production, quality/QA/QC, technique, EHS)
  • markets
    • Switzerland, DACH/EU/Europe, USA, SA, Asia (China, Korea, etc), Emergine, etc.
  • customer (focus):
    • small-medium-sized companies, global player/multinational/Big Pharma enterprises, MAHs, CMOs, OEMs, industrial/chemical parks/company sites, etc.
  • references
    • Roche, J&J/Janssen Cilag, Acino Pharmaceuticals, Catalent, Novartis, Alcon, Sandoz, Lonza, BioNTech, Panpharma / Rotexmedica, WuXi Biologics/Astra Zeneca, RFS, EBEWE, HMR/Aventis, Bayer, Pfizer, Fresenius, Grünenthal/dalli, Membrana, BASF, Hoechst/HMR/Aventis, Celanese, Ticona, Vintron, Henkel, Alstom, BP, Ineos/Innovene, Jowat, G+H/Isover, Martinswerk, P&G/WELLA, etc.
  • products
    • APIs, clinicals / commercials, generics, drug products (dosage form: solida, liquida, semi / combinations, scale ups, spin offs), vaccines, biologics/biosimilars, proteins, ATMPs, AWK, SM/IMPs, INDs, cell cultures, oncology, therapeutic antibodies, immune cell cultures, microorganism, bacteria/yeasts, nutrients, RNA (A,B) / mRNA / DNA / cDNA, plasmids, proteins / oligo, penicilline, recombinations hormones, anti-infectives, inhibitors, inflammables, vitamins, anti-infectives, combinations, OTCs, BTM, MDs (Cl. I-III)/IVDs, MDR/IVDR, chemicals, plastics, adhesives
  • authorities
    • FDA, EMA, Swissmedic, ANVISA, CFDA, KFDA, TPD, SFKN, CMDCAS, regional
  • Program / Project Management
    • (on site, site to site, comprehensive), CAPEX / investment projects (up to 150 Mio CHF), cross-functional & interdisciplinary projects, international and roll-outprojects, etc. 
    • developments, scale-ups, production, all study phases, launch / bring in the market, spin offs, transfers products & technique, MAH and CMOs, etc. 
    • PMI / PMO tools, PM and programs (i.a. handbooks, trainings, project organization and team building, agile methods, etc.) 
    • total project and program phases: project evaluation and designing, operationalization, changes/success, project reviews, closing phases, project risk management / risk-based approach, troubleshooting, change management 
    • project / program scheduling and handling, Agile / SCRUM, timelines and milestones, tracking project tasks and actions, features and budget controlling and monitoring, project reporting, etc.
  • head of manager in Corporate, Quality (QA / QC), RA, compliance and Senior Consultant (Pharma / Medical Devices / Chemistry)
    • construction, change and installation Corporate, Quality (staff), QA / QC, site large-scale organizations, quality CAPEX / investment programs
    • QMS/IMS: Global/Corporate, on site, implementation, risk-based approach, setups, reviews, cGMP/GMP/GDP/GxP compliance, ICH Q10, ISO 9001, HLS, 13485, 15378, 21 CFR 820, MDR, IVDR, EFQM/TQM, ISO 27001, standards, SOP management, harmonization, DCM/eDMS, integrated systems, MES, process management, SIPOC, QCP, KQIs/CIP, SFM/ Quality on the Floor, audit system, external/supplier auditing, MDSAP, CMDCAS, etc. 
    • inspection readiness / remediation programs: FDA, EMA, Swissmedic, ANVISA, CFDA/SFKN/KFDA, regional authorities, QSIT, remediation, PAI, MDSAP, etc. 
    • accountable / responsible Quality, QMS and QA: release/BRR/QP business, cGMP/GxP, MDR/IVDR, § 52a AMG, QMS and quality management, quality oversight (FDA/cGMP, GMP/GDP, MDR/IVDR), CMO management, GQRB/QRB, releases (drugs, biologics, vacinnes, etc.), quality by design, PPQ management, CTD/BLA, CMC, reviews, OCM, CHC, assessment/GAP, escalations/recalls/ complaints, QA production/packaging, warehouse/logistic/distribution, authority reports, MSO, process validation, VDM, PQR/AQR, PDRs, complaints/ deviation/CAPA management, CC, data matrices/data integrity, supplier qualification, QAA/QSV, PV, OOS/OOE, etc.
    • chemistry, manufacturing & control (CMC): all stages / phases drug / biologics development life cycle, clinical phases I-III, scale-ups, manufacturing processes / USP/ DSP, CTD/ BLA, PPQ, process validation, stability testing / analytics, products: NDA/INDs, SM / LM / peptides, biologics / biosimilars, vaccines, etc. 
    • analytics and quality Control: i.a. management/strategy/operation/customer services/sales, lean management/leanLab, Visual Inspection / Kits / Qualification / MiBi, AQL management, QC performance/processes/ IPKs/releases, QC & analytic internal/external, contract laboratory, compliance (OOS/OOE, asset, dissolution, purity, stability, etc.), analytic methods (chromatography and testing: HPLC, GC-MS, atomic, molecular, elemental & classical, etc), trouble shootings, GLP/cGMP/GMP/ GxP, ISO 9001/17025, REACH, MDR, method validation/reports, etc.), QC programs (launch/studies/ bring in the market, etc.), MiBi, QC aseptic/sterile processes, visual inspection, APS, McFarland, filling volume, read out, qualification, REACH (SDS/SDB, tox-/öko-tox, (pre)registrations, only representative, EU twinning program) etc. 
    • risk management: i.a. site risk assessments, incident management, FDA risk based approach, risk strategy, GAP analyses, FMEA/HACCP, risk control, risk audit systems, ICH Q9, ISO 14971, MDR /IVDR, etc. 
    • clinical studies and regulatory affairs: i.a. CMC, GCP, study phases I-IV, CDMR, REACH, regulatory strategy/management, etc. 
    • trainings amd qualifications (i.a. concepts/programs, management training, , workshops, Knapp qualification, etc.).
  • site head EHS / head of manufacturing, compliance and senior consultant, EHS referent, TGA accredited environmental Auditor, responsible care representative, REACH expert (i.a. EU twinning projects), BG Chemistry trainer chemical parks
    • EHS / SGU compliance and services (i.a. lead ASCA program, FFM, industrial / chemical parks) 
    • EHS and integrated management systems (i.a. EHS/IMS, cGMP/GMP, EMAS/ISO 14001, HLS, 45001, OSHA 18001, 51001, SCC, excellence road maps, safety management) 
    • EHS risk management and site risk assessment (i.a. hazard and GAP analyses, process safety, CAPAs, etc.), EHS audits and inspections o EHS media: i.a. hazardous substance management / REACH, immission protection, water protection, soil protection, waste and contamination management, incineration plants, process and plant safety, event/crisis/ emergency management and communication, site representative, product safety, fire protection, bio safety, hygiene (aseptic behaviour / production, etc.)
    • EHS leading, construction and continuous improvement, legal safety organizations, excellence road maps, external company management 
    • EHS regulation, authority and stakeholder management (i.a. ministries, regional authorities, WHO / EU / etc., associations / VCI / BDI / etc., Swissmedic / SECO / etc.) 
    • trainings: i.a. qualifications, concepts/programs, management, workshops, etc.
  • head of manager in manufacturing / production / operations / packaging / engineering / technique / storage / EHS and senior consultant (Pharma / Medical Devices / Chemistry)
    • construction, change and installation operations / production, SFM, EHS organizations 
    • inspection readiness / remediation programs: FDA, EMA, Swissmedic, ANVISA, CFDA/SFKN/KFDA, regional authorities, QSIT, remediation, PAI, MDSAP, etc. 
    • operations/production management: i.a. construction / planning production, batches, scale ups, line management, operational supervising, BRR, maintenance/qualification phases, cGMP/GMP/GDP/GxP compliance (drug/liquida/solida, biologics, vacinnes, MDRs/IVDRs, Cl. I-III, APIs, etc.), qualification runs, production/corporate standards and performance, batchwise production incl. (excellence / lean) processes etc., MBR, aseptic/sterile production/lines, monitoring, MiBi, lead resources/personnel/ products, PPS, SFM, SCM, MS&T, engineering, processing raw materials, KPIs, Right-First- Time/PAS-X/EBR/ OEE, productivity, delivery/cost/inventory/ test reduction, etc., IPC/visual inspection, Knapp qualification, defect data bank, etc. 
    • biologic processes: (aseptic) fermentation: i.a. USP/DSP, fermenter/reactor, single-use system, bio-reactor, photo/moos bio reactors, CHO / BHK / Vero / NSP-GS cell lines, airlift-/membran- reactors, cell reactor, microorganism / mushroom cultures / plasmids, ion exchange, catalyse, viral vectors / mRNA, control elements, promotor, enhancer, receptors, master / working seeds, preparation, storage, isolation, cultivation, expansion, enrichment, extraction, sterile / gel filtration, centrifugation, cleaning, sterilization / decontamination, inactivation, parameters, neutralization, bio conversion, bio processing
    • techniques: USP/DSP, scale-ups, aseptic production, sterile production, cleanroom A-E, plants biotechnology/ pharma/chemistry, facility management/construction, maintenance, CAPEX/investments, TGA, infrastructure/security, facility supply and maintenance, air pressure/air condition/HVAC, monitoring systems/CAD, etc., operating technology (filling-, RABS-, isolator-, batch- systems, vial-/ampule-/injectable lines), automatization, lyophilization, crimping, washing and tunnel, pressure vessel, granulation, extraction, preparation, coating and deposition, conti-systems, high pressure systems, pipelines, distillation systems, VAwS plants, stirrer tanks, containment, packaging, qualifications, ECC, risk-based approach, URS, DQ-PQ, FAT, TAT, validation, media-fills, qualification-runs, sterilization, pumps, stirrer systems, WFI / WBI, lyophilization, crimping, packaging (ESAI, ESA, Mashimpex track&trace, serialization, etc.), etc. 
    • qualification & validation: i.a. VPM URS, DQ-PQ(I/II), Q review, pharma technique, plants/equipment, utilities, facilities, processes, media-fill, processvalidation, PCD, IT-systems, SAT, TAT, FAT, data integrity o transfer and transaction business: i.a. local/site to site/Swiss/EU/US/SA/Asia market, all transfer phases, carve outs, evaluation, project management, project design, operationalization, closes, i.a. USP/DSP, scale-ups, entity, sites, plants, products/ lines, production/operations, equipment, HAVC, management, systems, processes, R&D/analytics/methods, packaging, etc. 
    • testing (assessment / controlling / QC procedures): i.a. IPCs, GRAS, identity, purity / impurity, stability, effectiveness, reduction rate, reaction time, pH / O2 / CO2, tox / kinetic, antibiotics, HCPs, enzymes, southern-blot, PCR, risk evaluation, applications, chromatography methods, reversed phase, in-process analytic, HPLC, FPLC, etc., waste management, visual inspections (optical / manual / half automatic / automatic processes and systems), etc. 
    • aseptic behavior programs: i.a. hygienic / sterile processes, aseptic production, laboratory, storage/logistics, trainings, workshops, etc. 
    • strategy & performance management: i.a. CAPEX / Multiple programs, production/product strategy/production plants, digitalization, 4.0/MES, legal safety organization, awareness/mindset programs, team-building, SCM/sourcing strategy, B2B/B2C/ CMO business, R&D and portfolio programs, bring in the market/spin offs/new dosage forms, buy-in/out, lean/shop floor management and production, Best in Class/BPE/excellence programs, Six Sigma, change management, MCRS/ Reporting, due dilligence, turnarounds, SWOT/5-box analyses, road maps, etc.
    • change / transformation (trsf) management: all phases, visions and change strategies, project / transformation / re-engineering / crises management, mindset / awareness program, large-scale (global, on site) and medium-sized procedures and processes, project, teambuilding, progress and method management (i.a. change shop, MES/4.0, ESM, change compass), change effectiveness, measurements, problem-solving and risk management, (GAP, 5- box, etc.) analyses and requirements, training and engagement optimization, teambuilding, empowerment strategy and realization, integrated strategies, systems and processes, regulatory compliance, etc. 
    • supply chain management: i.a. SCM/SCOR/SSCM, Sourcing - single/multi, procurement, life cycle, supplier/vendor management, etc. 
    • trainings: i.a. concepts/programs, management training, workshops, etc.
  • IT / IT QA
    • PMO/PMI tools, MS office, MS project, SAP (since 2009), ERP (since 2010), Office (since 1998), change shop, ESM, change compass, MES/4.0 (since 2017), LIMS since 2011), e-learning systems (since 2012), PMO tools (since 2012), TrackWise (since 2010), ennov (2019), biomedion (2019), data integrity, ISO 27001

Publications: on request

  • pharmaceutical
  • biotechnology
  • medical device
  • chemical
  • human contact
  • cosmetic, food
  • plant engineering
  • logistic
  • refining industry
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