Overall: Establishing, renewing and maintaining Quality Systems, SOPs, hiring and
training of employees in the GMPs, ensure compliant behaviour of the personnel.Self inspections (internal Audits), customer complaints, scientific response to consumer questions, qualification, validation, transfer, change control management, risk mamagement, deviation management and CAPAs, risk analysis, hosting and conducting authorities and external Audits (eg. qualifying audits at contract manufacturers), supervising labworks (HPLC,GC, …), batch record review, batch certification and release to market, liquid, semisolid and solid dosage forms, handling of drug risks.
e.g. as
Head of Quality
Qualified Person (QP) acc. to §14 AMG (German Drug Law) (referring to 2001/83/EC, Art. 48)
Head of Quality Control (HQC)
Head of Production (HP)
QPPV (Stufenplanbeauftragter)
Responsible person for narcotics (BtM-Verantwortlicher)
Informationsbeauftragter
Qualified Person (QP) acc. to §14 AMG (German Drug Law) (ref. to 2001/83/EC, Art. 48)
Head of Production (HP)
Deputy QPPV (stellv. Stufenplanbeauftragter), stellv. Infobeauftragter at docpharm Arzneimittelvertrieb GmbH &Co KGaA – Karlsruhe, Germany docpharm sells generics as well as in house repacked parallel imported medicinal products As QP: Batch Record Review, Release to market, qualifying audits at contract manufacturers (external audits)
As HP : establishing a secondary packaging unit with more than 20 people “from scratch“. Including e.g. SOPs, hiring and training of employees. Start was 08.2010. Further (as QP also for Generics) involved in qualification, validation,
change control, SOPs, audits, self inspections, deviation management and CAPAs, complaints, trainer for GMP.
Deputy of QPPV and of Informationsbeauftragter
European P&G Plant for VICKS/ WICK Products, producing for markets in Europe, both Americas (incl. Brasil and USA), Australia, New Zealand, Africa and Asia.
Procter & Gamble, a famous householdcare company has an medicinal products branch to produce and sell
VICK'S/WICK OTC products Batch record review, batch certification and release for shipment to the orderer.
For Germany and parts of Europe also final release.
As plant QP and HQC deeply involved in inspection hosting, qualification,validation, change control, risk management, SOPs, self inspection, deviation handling, CAPAs, method transfer and in internal auditing.
Furthermore plant owner of QA KeyElement customer & consumer lernings & response (owner of complaint-system). Owner os stability programme. Trainer for statistics.
Supporting Regulatory Affairs e.g. by confirming the qualification of suppliers
Batch record review, GMP trainings, SOPs, internal auditing
Assistant of EPP's QP acc. to §14 AMG and assistant of EPP's Head of Production.
furthermore:
Responsible person of EPA for narcotics (Betäubungsmittel-Verantwortlicher) acc. to.BtMG (German Law on Narcotics). Responsing to harmaceutical and pharmacological requests of healthcare professionals and to consumer complaints.
Prescriptions, client counselling and selling OTC, compounding prescriptions,responsible Pharmacist, when owner is out of office
I.a. setting up a QM system as QMB = QualitätsManagementBeauftragter (Quality
Management Officer) I.a. Illness cover of the owner with full pharmaceutical responsibility for 3 months.
analysing starting materials acc. to pharmacopoeia, also preparation of medcines/ compounding prescriprions
Instrumental analytics of digestive enzymes
Dept. Digestive Enzyme Research (Kreon)
Quality Professional,
? Degree in Pharmacy
? Experience working in a regulated environment (pharmaceutical products, medical devices)
? Profund knowledge in international regulations and guidelines (EU / FDA cGMP regulations, GDP guidelines, ICH etc.)
? Experience working in an international and cross-functional environment
? Strong analytical and problem solving skills
? Excellent writing, speaking and and negotiation skills (German, English), Team player with well-developed interpersonal abilities
? Proactive, persistent, problem solving and can-do attitude
? Ability to communicate to people of different professional level
? Flexible, highly motivated, with strong organization skills, Ability to travel
? Experience in hosting and following-up of authority inspections including pre-approval inspections
Overall competencies:
Leadership
GMP?s, GDP, GLP
Hosting inspections of authorities and audits,
Conducting external Audits (eg. qualifying audits at contract manufacturers),
Batch record review,
Batch certification
Release to market
Establishing, renewing and maintaining Quality Systems,
Writing. reviewing or approving SOPs,
Training of employees in the GMPs and in statistics
Ensure compliant behaviour of the personnel.
Self inspections (internal Audits),
Continuous improvement / Self improvement program
Change control management,
Qualification, validation, transfer,
Analytical method transfer
Risk mamagement, Risk analysis, FMEA
Deviation management, CAPAs and follow-up and reporting
Supervising labworks (HPLC,GC, ?),
Liquid, semisolid and solid dosage forms,
Scientific response to consumer questions,
Managing customer complaints,
Handling of drug risks.
July 16th 1996
University and School
License as pharmacist (Approbation als Apotheker)
Bayer. Staatsministerium f. Arbeit und Sozialordnung, Familie, Frauen und Gesundheit? (Bavarian MoH, ...) Munich, Germany
1990-1995
Pharmacy studies at university
Julius-Maximilians-Universität ? Würzburg i.a. with Professor Czygan, Ebel, Herdeis, Riehl, Zimmermann
1980 ?1989
University entrance diploma (?Abitur?)
Clavius-Gymnasium (German flavour of high school/college i.e. 5 th -13th form) ? Bamberg
specialized courses: Chemistry and Mathematics
Additional qualifications / Memberships
Since2009
Membership
European Qualified Person Association (EQPA)
2002
QMS-Auditor Qualification
Six days training according DIN ISO 9001:2000 and BLAK-specific contents
Bavarian pharmacists chamber (BLAK) / Dr. G. Emeis ? Munich
2001 -2003
Tutor at adult college (second job)
Adult college (Bildungszentrum (VHS) Nürnberg) ? Nuremberg
in 'Healt and Environment / Pharmacy' department
Lectures, partly with practical exercises, e.g. preparing an ointment by yourself
1996 -1998
Tutor for Pharmacology at nurse school (second job)
School for elderly care nurses (Fachschule Altenpflege der GGBH) ? Hildesheim
1992 - 1995
Radio presenter for a morning programme on Sunday
Aufgew8. (Freie evang. Gemeinde / Radio Gong) ? Würzburg
Seminar, training and other
Certificates of the pharmaceutical examination
Degree in Pharmacy
Qualified Person (QP) for medicinal products
Qualified Person (QP) for APIs
Head of Quality
Head of Quality Assurance
Head of Qualiuty Control
Head of Production
Leadership
Establishing, renewing and maintaining Quality Systems,
GMP?s, GDP, GLP
Writing, reviewing or approving SOPs,
Training of employees in the GMPs, Training in statistics
Ensure compliant behaviour of the personnel,
Self inspections (internal Audits),
Continuous improvement / Self improvement program
Change control management,
Risk mamagement, risk analysis, FMEA
Qualification, validation, transfer, analytical method transfer
Batch record review,
Batch certification
Release to market
Hosting inspections of authorities and audits,
Conducting external Audits (eg. qualifying audits at contract manufacturers),
Deviation management, CAPAs and follow-up and reporting
Supervising labworks (HPLC,GC, ?),
Scientific response to consumer questions,
Managing customer complaints,
Handling of drug risks.
MS Windows XP, 8, 10, Word , Excel, Powerpoint, Outlook.
Linux (openSuSE, Ubuntu) und applications (e.g. OpenOffice, Firefox, Thunderbird)
SAP und Movex (ERP)
Skiing, bicycling, swimming, Karate (8. Kyu, currently inactive)
? Degree in Pharmacy
? Experience working in a regulated environment (pharmaceutical products, medical devices)
? Profund knowledge in international regulations and guidelines (EU / FDA cGMP regulations, GDP guidelines, ICH etc.)
? Experience working in an international and cross-functional environment
? Strong analytical and problem solving skills
? Excellent writing, speaking and and negotiation skills (German, English), Team player with well-developed interpersonal abilities
? Proactive, persistent, problem solving and can-do attitude
? Ability to communicate to people of different professional level
? Flexible, highly motivated, with strong organization skills, Ability to travel
? Experience in hosting and following-up of authority inspections including pre-approval inspections
Overall:
Hosting inspections of authorities and audits, conducting external Audits (eg. qualifying audits at contract manufacturers), Release to market
Batch record review, batch certification
Establishing, renewing and maintaining Quality Systems, Maintaining SOPs,
Hiring and training of employees in the GMPs, Training in statistics
Ensure compliant behaviour of the personnel. Self inspections (internal Audits), Continuous improvement / Self improvement Qualification, validation, transfer, change control management, Analytical method transfer
Risk mamagement, risk analysis, FMEA
Deviation management, CAPAs and follow-up and reporting Supervising labworks (HPLC,GC, ?), Liquid, semisolid and solid dosage forms, Scientific response to consumer questions, Managing customer complaints, Handling of drug risks.
Pharma
Arzneimittel
Parallelimporte
Reimporte
Importe
Overall: Establishing, renewing and maintaining Quality Systems, SOPs, hiring and
training of employees in the GMPs, ensure compliant behaviour of the personnel.Self inspections (internal Audits), customer complaints, scientific response to consumer questions, qualification, validation, transfer, change control management, risk mamagement, deviation management and CAPAs, risk analysis, hosting and conducting authorities and external Audits (eg. qualifying audits at contract manufacturers), supervising labworks (HPLC,GC, …), batch record review, batch certification and release to market, liquid, semisolid and solid dosage forms, handling of drug risks.
e.g. as
Head of Quality
Qualified Person (QP) acc. to §14 AMG (German Drug Law) (referring to 2001/83/EC, Art. 48)
Head of Quality Control (HQC)
Head of Production (HP)
QPPV (Stufenplanbeauftragter)
Responsible person for narcotics (BtM-Verantwortlicher)
Informationsbeauftragter
Qualified Person (QP) acc. to §14 AMG (German Drug Law) (ref. to 2001/83/EC, Art. 48)
Head of Production (HP)
Deputy QPPV (stellv. Stufenplanbeauftragter), stellv. Infobeauftragter at docpharm Arzneimittelvertrieb GmbH &Co KGaA – Karlsruhe, Germany docpharm sells generics as well as in house repacked parallel imported medicinal products As QP: Batch Record Review, Release to market, qualifying audits at contract manufacturers (external audits)
As HP : establishing a secondary packaging unit with more than 20 people “from scratch“. Including e.g. SOPs, hiring and training of employees. Start was 08.2010. Further (as QP also for Generics) involved in qualification, validation,
change control, SOPs, audits, self inspections, deviation management and CAPAs, complaints, trainer for GMP.
Deputy of QPPV and of Informationsbeauftragter
European P&G Plant for VICKS/ WICK Products, producing for markets in Europe, both Americas (incl. Brasil and USA), Australia, New Zealand, Africa and Asia.
Procter & Gamble, a famous householdcare company has an medicinal products branch to produce and sell
VICK'S/WICK OTC products Batch record review, batch certification and release for shipment to the orderer.
For Germany and parts of Europe also final release.
As plant QP and HQC deeply involved in inspection hosting, qualification,validation, change control, risk management, SOPs, self inspection, deviation handling, CAPAs, method transfer and in internal auditing.
Furthermore plant owner of QA KeyElement customer & consumer lernings & response (owner of complaint-system). Owner os stability programme. Trainer for statistics.
Supporting Regulatory Affairs e.g. by confirming the qualification of suppliers
Batch record review, GMP trainings, SOPs, internal auditing
Assistant of EPP's QP acc. to §14 AMG and assistant of EPP's Head of Production.
furthermore:
Responsible person of EPA for narcotics (Betäubungsmittel-Verantwortlicher) acc. to.BtMG (German Law on Narcotics). Responsing to harmaceutical and pharmacological requests of healthcare professionals and to consumer complaints.
Prescriptions, client counselling and selling OTC, compounding prescriptions,responsible Pharmacist, when owner is out of office
I.a. setting up a QM system as QMB = QualitätsManagementBeauftragter (Quality
Management Officer) I.a. Illness cover of the owner with full pharmaceutical responsibility for 3 months.
analysing starting materials acc. to pharmacopoeia, also preparation of medcines/ compounding prescriprions
Instrumental analytics of digestive enzymes
Dept. Digestive Enzyme Research (Kreon)
Quality Professional,
? Degree in Pharmacy
? Experience working in a regulated environment (pharmaceutical products, medical devices)
? Profund knowledge in international regulations and guidelines (EU / FDA cGMP regulations, GDP guidelines, ICH etc.)
? Experience working in an international and cross-functional environment
? Strong analytical and problem solving skills
? Excellent writing, speaking and and negotiation skills (German, English), Team player with well-developed interpersonal abilities
? Proactive, persistent, problem solving and can-do attitude
? Ability to communicate to people of different professional level
? Flexible, highly motivated, with strong organization skills, Ability to travel
? Experience in hosting and following-up of authority inspections including pre-approval inspections
Overall competencies:
Leadership
GMP?s, GDP, GLP
Hosting inspections of authorities and audits,
Conducting external Audits (eg. qualifying audits at contract manufacturers),
Batch record review,
Batch certification
Release to market
Establishing, renewing and maintaining Quality Systems,
Writing. reviewing or approving SOPs,
Training of employees in the GMPs and in statistics
Ensure compliant behaviour of the personnel.
Self inspections (internal Audits),
Continuous improvement / Self improvement program
Change control management,
Qualification, validation, transfer,
Analytical method transfer
Risk mamagement, Risk analysis, FMEA
Deviation management, CAPAs and follow-up and reporting
Supervising labworks (HPLC,GC, ?),
Liquid, semisolid and solid dosage forms,
Scientific response to consumer questions,
Managing customer complaints,
Handling of drug risks.
July 16th 1996
University and School
License as pharmacist (Approbation als Apotheker)
Bayer. Staatsministerium f. Arbeit und Sozialordnung, Familie, Frauen und Gesundheit? (Bavarian MoH, ...) Munich, Germany
1990-1995
Pharmacy studies at university
Julius-Maximilians-Universität ? Würzburg i.a. with Professor Czygan, Ebel, Herdeis, Riehl, Zimmermann
1980 ?1989
University entrance diploma (?Abitur?)
Clavius-Gymnasium (German flavour of high school/college i.e. 5 th -13th form) ? Bamberg
specialized courses: Chemistry and Mathematics
Additional qualifications / Memberships
Since2009
Membership
European Qualified Person Association (EQPA)
2002
QMS-Auditor Qualification
Six days training according DIN ISO 9001:2000 and BLAK-specific contents
Bavarian pharmacists chamber (BLAK) / Dr. G. Emeis ? Munich
2001 -2003
Tutor at adult college (second job)
Adult college (Bildungszentrum (VHS) Nürnberg) ? Nuremberg
in 'Healt and Environment / Pharmacy' department
Lectures, partly with practical exercises, e.g. preparing an ointment by yourself
1996 -1998
Tutor for Pharmacology at nurse school (second job)
School for elderly care nurses (Fachschule Altenpflege der GGBH) ? Hildesheim
1992 - 1995
Radio presenter for a morning programme on Sunday
Aufgew8. (Freie evang. Gemeinde / Radio Gong) ? Würzburg
Seminar, training and other
Certificates of the pharmaceutical examination
Degree in Pharmacy
Qualified Person (QP) for medicinal products
Qualified Person (QP) for APIs
Head of Quality
Head of Quality Assurance
Head of Qualiuty Control
Head of Production
Leadership
Establishing, renewing and maintaining Quality Systems,
GMP?s, GDP, GLP
Writing, reviewing or approving SOPs,
Training of employees in the GMPs, Training in statistics
Ensure compliant behaviour of the personnel,
Self inspections (internal Audits),
Continuous improvement / Self improvement program
Change control management,
Risk mamagement, risk analysis, FMEA
Qualification, validation, transfer, analytical method transfer
Batch record review,
Batch certification
Release to market
Hosting inspections of authorities and audits,
Conducting external Audits (eg. qualifying audits at contract manufacturers),
Deviation management, CAPAs and follow-up and reporting
Supervising labworks (HPLC,GC, ?),
Scientific response to consumer questions,
Managing customer complaints,
Handling of drug risks.
MS Windows XP, 8, 10, Word , Excel, Powerpoint, Outlook.
Linux (openSuSE, Ubuntu) und applications (e.g. OpenOffice, Firefox, Thunderbird)
SAP und Movex (ERP)
Skiing, bicycling, swimming, Karate (8. Kyu, currently inactive)
? Degree in Pharmacy
? Experience working in a regulated environment (pharmaceutical products, medical devices)
? Profund knowledge in international regulations and guidelines (EU / FDA cGMP regulations, GDP guidelines, ICH etc.)
? Experience working in an international and cross-functional environment
? Strong analytical and problem solving skills
? Excellent writing, speaking and and negotiation skills (German, English), Team player with well-developed interpersonal abilities
? Proactive, persistent, problem solving and can-do attitude
? Ability to communicate to people of different professional level
? Flexible, highly motivated, with strong organization skills, Ability to travel
? Experience in hosting and following-up of authority inspections including pre-approval inspections
Overall:
Hosting inspections of authorities and audits, conducting external Audits (eg. qualifying audits at contract manufacturers), Release to market
Batch record review, batch certification
Establishing, renewing and maintaining Quality Systems, Maintaining SOPs,
Hiring and training of employees in the GMPs, Training in statistics
Ensure compliant behaviour of the personnel. Self inspections (internal Audits), Continuous improvement / Self improvement Qualification, validation, transfer, change control management, Analytical method transfer
Risk mamagement, risk analysis, FMEA
Deviation management, CAPAs and follow-up and reporting Supervising labworks (HPLC,GC, ?), Liquid, semisolid and solid dosage forms, Scientific response to consumer questions, Managing customer complaints, Handling of drug risks.
Pharma
Arzneimittel
Parallelimporte
Reimporte
Importe
Direktester geht's nicht! Ganz einfach Freelancer finden und direkt Kontakt aufnehmen.