Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 30.06.2026
Verfügbar zu: 70%
davon vor Ort: 100%
Qualitätssicherung
Good Manufacturing Practice
Changemanagement
Good Documentation Practice
Reklamationsmanagement
Good Distribution Practice
Healthcare
Validierung
Good Auditing Practice
Auditor
Projekte
Contract Manufacturing Company (CMO) consulting in the environment of Quality matters
- Validating and batch documentation assessments & disposition proposals
- Processing validation concept alignment
- Completing NDMA assessment for API and DP, ICH Q3D assessment
- Changing control initiation, Vetting & action management
- Deviation, investigation CAPA management
- Quality agreement update maintenance
- CMO Audit & CAPA Management
Oral dosage form
Freelance Activities, Coach
- Establishment of Coaching Business
- Training in Coaching Methods
Head of Quality Unit
Vitane Pharma GmbH/ Deputy QP
Head of Corporate Quality Release
- Centralized Release Functions ? QP Organization
- Release Group Non-Pharma Products (Medical Devices, Food Supplements and Cosmetics)
STADA Arzneimittel AG
- Global Complaint Management/ Qualified Person
STADA Arzneimittel AG
Bayer AG, Supply Center
Leverkusen, Germany
Qualified Person/ Team Leader Quality Control External Pharma Products
STADA Arzneimittel AG
Head of Quality Assurance, Head of Quality Control, Qualified Person (starting from 09/2010)
Fresenius Kabi Production Unit Third Party Manufacturing
- FDA-Compliance Project (Aseptic Manufacturing Process)
- Transfer Project of Oral Dosage Product
- GMP-Compliance Projects
- Contract Manufacturer Support
- Corporate SOPs
- Internal and External Audits
- Regulatory CMC
Fresenius Kabi (GMP- Compliance Group)
Port Elizabeth/ South Africa
Frankfurt am Main
Aus- und Weiterbildung
Regierungspräsidium Darmstadt, Germany
State examination and registration as Pharmacist
Johann Wolfgang von Goethe Universität Frankfurt am Main
Position
- Beratung/ Consulting
- Qualitätsmanagement/ Qualitätssicherung von Arzneimitteln
- Sachkundige Person (Freigabe von Arzneimitteln nach § 14 AMG)
- Reklamationsmanagement
- Change Management
- CMO Management
- Audits
Kompetenzen
Top-Skills
Qualitätssicherung
Good Manufacturing Practice
Changemanagement
Good Documentation Practice
Reklamationsmanagement
Good Distribution Practice
Healthcare
Validierung
Good Auditing Practice
Auditor
Produkte / Standards / Erfahrungen / Methoden
Good Manufacturing Practice
Projekte
Contract Manufacturing Company (CMO) consulting in the environment of Quality matters
- Validating and batch documentation assessments & disposition proposals
- Processing validation concept alignment
- Completing NDMA assessment for API and DP, ICH Q3D assessment
- Changing control initiation, Vetting & action management
- Deviation, investigation CAPA management
- Quality agreement update maintenance
- CMO Audit & CAPA Management
Oral dosage form
Freelance Activities, Coach
- Establishment of Coaching Business
- Training in Coaching Methods
Head of Quality Unit
Vitane Pharma GmbH/ Deputy QP
Head of Corporate Quality Release
- Centralized Release Functions ? QP Organization
- Release Group Non-Pharma Products (Medical Devices, Food Supplements and Cosmetics)
STADA Arzneimittel AG
- Global Complaint Management/ Qualified Person
STADA Arzneimittel AG
Bayer AG, Supply Center
Leverkusen, Germany
Qualified Person/ Team Leader Quality Control External Pharma Products
STADA Arzneimittel AG
Head of Quality Assurance, Head of Quality Control, Qualified Person (starting from 09/2010)
Fresenius Kabi Production Unit Third Party Manufacturing
- FDA-Compliance Project (Aseptic Manufacturing Process)
- Transfer Project of Oral Dosage Product
- GMP-Compliance Projects
- Contract Manufacturer Support
- Corporate SOPs
- Internal and External Audits
- Regulatory CMC
Fresenius Kabi (GMP- Compliance Group)
Port Elizabeth/ South Africa
Frankfurt am Main
Aus- und Weiterbildung
Regierungspräsidium Darmstadt, Germany
State examination and registration as Pharmacist
Johann Wolfgang von Goethe Universität Frankfurt am Main
Position
- Beratung/ Consulting
- Qualitätsmanagement/ Qualitätssicherung von Arzneimitteln
- Sachkundige Person (Freigabe von Arzneimitteln nach § 14 AMG)
- Reklamationsmanagement
- Change Management
- CMO Management
- Audits
Kompetenzen
Top-Skills
Qualitätssicherung
Good Manufacturing Practice
Changemanagement
Good Documentation Practice
Reklamationsmanagement
Good Distribution Practice
Healthcare
Validierung
Good Auditing Practice
Auditor
Produkte / Standards / Erfahrungen / Methoden
Good Manufacturing Practice
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