a Randstad company

Quality and Compliance professional within pharmaceutical and biotech industry. Experience is within QC and QA for QC

Profil
Top-Skills
Compliance management Deviation management Qualitymanagement Risikomanagement Laboratory management Data integrity 21 CFR EU-GMP FDA audit readiness Audit support QC testing readiness technology transfer Validierung Instrument qualification stability studies QC release management Changemanagement CAPA Qualitätssicherung method transfer QC project management
Verfügbar ab
02.01.2023
Noch verfügbar - Schnell sein lohnt sich: Der Experte kann bereits für Projekte vorgesehen sein.
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100%
davon vor Ort
100%
Einsatzorte

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

2 Jahre 2 Monate

2020-12

heute

Various Projects

QUALITY SPECIALIST CONSULTANT
Rolle
QUALITY SPECIALIST CONSULTANT
Projektinhalte

Providing quality services for GMP pharmaceutical and Biotechnology industry. Completed assignments are as follows:

1 year and 2 months

Role: COMPLIANCE SPECIALIST (SENIOR TS)

Customer: Lonza Cell & Gene Therapy, NL


Key Responsibilities:

Quality Control & Microbiology Department

  • Coordinate activities related to deviations, CAPAs, change controls and client audits between teams and stakeholders 
  • Lead QC in audit preparation, discuss audit findings, define follow up actions with stakeholders, prepare response reports along with remediation actions 
  • Manage indirect reports in investigation performance, CAPA and change implementation 
  • Lead continuous improvement projects as part of site KPI and risk register 
  • Manage OTC of QC related audit observations and quality events by liaising with stakeholders 
  • Identify and assess risks in process, prepare risk assessments (FMEA, risk matrix) and mitigation plans 
  • Prepare product impact assessments for major and critical deviations 
  • Manage challenging, in-depth investigations using investigational tools 
  • Investigate OOS/OOTs, review manufacturing investigations and prepare OOS investigation reports for stakeholders 
  • Review stability and method SOPs to ensure compliance with Lonza /regulatory guidelines 
  • Provide training and organize for cause trainings within QC 
  • Ensure compliance with site quality KPIs and periodically present quality/performance metrics 


Key Accomplishments:

  • Lead the quality event reduction project and brought the quality event overdues to zero by DEC 2021 
  • Initiated overdue reduction action plan for 2022 and achieved the KPI targets for Q1 and Q2 
  • Successful completion of defined quality actions for site inspection readiness and site risk register 
  • Transfer of paper-based OOS system to electronic system via TrackWise 


9 months

Role: TECHNICAL SPECIALIST (SENIOR QC SPECIALIST)

Customer: Janssen Pharmaceuticals, J & J, NL


Key Responsibilities:

Quality Control for Supply Chain and New Product Introduction (NPI) support

  • Collaborate with local/global NPI stakeholders for QC testing readiness and define timelines for deliverables 
  • Lead 3 NPI projects for method transfer from different analytical development J&J sites to QC department 
  • Analyze and update capacity planning including calculated hours required for validation and assay performance 
  • Lead a team of QC associates and technicians, provide training and clear direction by setting expectations, deliverables due dates 
  • Draft problem statement, process mapping and identifying process improvements 
  • Prepare validation protocols, plan QC testing and share reports for NPIs with stakeholders 
  • Create, review, and updates lab documentation and NPI supporting documents 
  • Conduct risk assessment, impact assessment and gap analysis for QC/NPI processes 
  • Responsible for deviation management, lead investigator for high impact deviations and defining CAPAs 
  • Lead and drive continuous improvement projects such as non-conformance reduction and human error reduction   


Key Accomplishments:

  • Successful technology transfer for 2 API-NPIs within QC bioassay 
  • Developed detailed project schedules for planning testing and tracking equipments, analysts and materials capacity 
  • Roll out non-conformance reduction strategies using DMAIC methodology 
  • Implementation of human factor reduction cascade within QC bioassay 

2 Jahre 11 Monate

2018-01

2020-11

Bioassay Department

QUALITY CONTROL SCIENTIST
Rolle
QUALITY CONTROL SCIENTIST
Projektinhalte

Key Responsibilities:

  • Oversee GMP bioanalytical testing for DS/DP, IPC and stability release 
  • Technical review of testing results and preparing COAs for release 
  • Lead and supervise QC technicians for DS/DP release testing and support problem solving 
  • Analysis and trending of analytical data and reporting any trends or atypical results 
  • Write and revise SOPs, draft plans and reports for assay qualification and validation for bioassays 
  • Qualification and release of reference materials and critical reagents in bioassay testing 
  • Investigate deviations, lab investigations, OOS/OOT and Root Cause Analysis through Quality tools 
  • Implementing Corrective and Preventive Actions (CAPA) and change controls 
  • Review and approve laboratory system validation and CSV reports 
  • Implement Data integrity guidelines within QC and review audit trail reports 
  • Lead continuous improvement projects in collaboration with stakeholders
  • Oversee and coordinate lab equipment lifecycle management 
  • Establishing GXP compliance and training QC personnel 
  • Maintain strict compliance with QMS, GMP, GDP and safety regulations 


Key Accomplishments:

  • Awarded Dynavax 2019 certificate of excellence for role in FDA audit readiness 
  • Minimized human error root causes and reoccurring deviations 
  • Implementing data integrity remediation and establishing audit trail SOP for QC lab systems 
  • Supporting inspection readiness team for German health authority inspection and remediation activities  

Kunde
Dynavax Europe
Einsatzort
Germany
1 Jahr 5 Monate

2016-08

2017-12

R&D & Quality Control Department

SCIENTIST
Rolle
SCIENTIST
Projektinhalte

Key Responsibilities:

  • Develop Hematology controls and calibrators for hematology analyzers 
  • Develop project plans and reports for release/stability studies 
  • Monitor IPC and GMP release QC testing of Hematology products 
  • Assess and troubleshoot product performance through the product lifecycle 
  • QA support through OOS/OOT investigations, MR, CAPA and root cause analysis (RCA) 
  • Create training material for new processes and measurement systems 
  • Implement and train staff on QC processes and GMP guidelines 
  • Plan and oversee lab related projects such as equipment qualification 
  • Ensure documentation and compliance through DHF, gap analysis & remediation 
  • Organize, communicate product updates and prepare department for internal and external audits


Key Accomplishments:

  • Successful conversion of CDS Hematology controls, for all customers, from glass into PP vials 
  • Completion of shipping stability studies on CDS calibrators for establishing shipping conditions

Kunde
Clinical Diagnostic Solutions
Einsatzort
USA-FL
3 Jahre 9 Monate

2012-04

2015-12

Develop functional assay services for pharmaceutical and biotechnology clients

RESEARCH ASSISTANT
Rolle
RESEARCH ASSISTANT
Projektinhalte

Key Responsibilities:

  • Develop functional assay services for pharmaceutical and biotechnology clients
  • Executed cellular assay optimization, qualification, and valid  
  • Implemented cellular assays, biochemical and immunoassay techniques 
  • Designed and executed cellular HTS and HCA/HCS for drug discovery projects 
  • Developed assays for Operetta high-throughput imager, FLIPR HTS platform and flow cytometry platform for cell target identification 
  • Documented SOPs, prepared presentations and demonstrated techniques to team members and stakeholders 
  • Coordinated successfully with team members on internal and external projects 
  • Accomplished long-term and short-term targets with full customer satisfaction


Key Accomplishment:

  • Successful development and completion of high content screening of 50,000 compounds for identification of novel DNA repair inhibitors  

Kunde
Evotec AG
Einsatzort
Germany
1 Jahr

2011-01

2011-12

Oncology and Hematology Department

STUDENT RESEARCH ASSISTANT
Rolle
STUDENT RESEARCH ASSISTANT
Projektinhalte

Key Responsibilities:

  • Establish the isolations and quantification of murine Mesenchymal Stem Cells (mMSCs) using cell surface markers 
  • Established flow cytometry protocols (FACS) for mMSC enrichme

Kunde
Biomedizinsches Zentrum
Einsatzort
Germany

2012-02

MASTER OF SCIENCE IN MOLECULAR BIOTECHNOLOGY

University Of Bonn, Bonn


2009-09

BACHELOR OF ENGINEERING IN BIOTECHNOLOGY

Visveswaraiah Technological University, Bangalore


CERTIFICATIONS:

  • Fundations in GMP Auditing - US Pharmacopeia (USP)
  • Measuring Process and Organization Performance - American Society for Quality (ASQ)
  • Quality Tools- Plan-Do-Study-Act Plus QToolsTM - American Society for Quality (ASQ)
  • Continual Improvement Assessment - American Society for Quality (ASQ)
  • Laboratory Controls: Anticipate the Systems based FDA inspections - cfPA
  • Development and validation of bioanalytical assays for biologics - cfPIE
  • Data analysis: Nonlinear Regression Analysis using Prism GraphPad - STATCON
  • Foundations of GMP Data Integrity and Computer System Validation ? US Pharmacopeia (USP)

Top Skills
Compliance management Deviation management Qualitymanagement Risikomanagement Laboratory management Data integrity 21 CFR EU-GMP FDA audit readiness Audit support QC testing readiness technology transfer Validierung Instrument qualification stability studies QC release management Changemanagement CAPA Qualitätssicherung method transfer QC project management
Produkte / Standards / Erfahrungen / Methoden

PROFILE:

Over 9 years technical experience in discovery and development projects to quality control in GMP manufacturing. Equipped with outstanding analytical and organizational skills to carry out tech transfer and develop effective QC procedures. Skilled in quality tools to address quality issues and implement efficient solutions. Ability to improve operational efficiency and to effectively carry out continuous improvements. Ability to lead and empower team members. Strong work ethics and excellent cross-cultural skills honed through interdepartmental and international collaboration.


SKILLS:

  • Quality Management: TrackWise, Tableau 
  • Document Management: MasterControl, TruVault 
  • Lab Management: LIMS, SmartQC, ELN 
  • Communication Management: MS Teams, Outlook, PowerPoint, Word 
  • Project Management: MS Project, Excel, Visio, Forms, Kanban board 
  • Data Analysis: GraphPad prism, XLFit, MATLAB 
  • Managing Multiple Projects via PDCA, Kanban, DMAIC 
  • Efficient Problem solving via RCA tools, Brainstorming, A3 problem solving report 
  • Risk Assessments via Process Mapping, Gap Analysis, FMEA, FTA, Risk Matrix, What-If Analysis 
  • Process and Continuous Improvement via PDCA, GEMBA walks, 5S, 5Whys, VSM, Poke-Yoke 
  • Compliance management via Deviation Investigation, CAPA, CAPA Effectiveness checks, Change Controls 
  • Data Integrity, lab equipment qualification and lifecycle management as per GAMP guidelines 
  • Regulatory and Audit support (FDA, EMA, German Health authority) 
  • Quality Trend Analysis and KPI tracking  

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