Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Planning and execution of worldwide internal audits at Fresenius Kabi organizations and country subsidiaries according to EU and FDA GMP regulations, WHO, ICH Guidelines, Pharmacovigilance regarding medicinal products and medical devices, ISO 13485, and ISO 9001.
Key responsibilities:
- Audit Lifecycle: Planning, scheduling, performing and follow-up of Global Internal Audits at:
- Preparation of trends from health authority inspection results
- Improvement of inspection readiness
- Performing training in various GMP topics for auditors and regular employees
Project Lead:
Process owner of supplier qualification system, quality assurance oversight of the local production unit, inspection management and readiness, implementation of corporate requirements
Key responsibilities:
· Supplier qualification: preparation of the annual audit plan for suppliers, monitoring and evaluation of suppliers, preparation of quality agreements with suppliers, follow up of corrective und preventive actions from the supplier audits, qualification of auditors
· Self-inspection program: preparation of the annual plan, execution of the self-inspections and flash checks
· Inspection management: hosting of health authority inspections and customer audits; consolidation of consequential corrective und preventive actions (CAPA)
· Representing Merck KGaA at the JAVfX (Joint Audit Verfahren für X= Excipients or Packaging Materials)
· Implementation of regulatory and corporate requirements and KPIs
· Processing of change controls, deviations, and complaints
· Quality Assurance review of documents regarding cleaning and process validation
Quality Assurance oversight of external packaging of clinical study medication (IMPs)
Key responsibilities:
· Supervising and guaranteeing all aspects of QA and timelines for external contract manufacturer
· Review of batch record documentation
· Approval of Master Batch Records
· Preparation of batch release for the Qualified Person
· Handling of deviations and technical complaints
Quality auditor
undefinedEudralex Vol .4 Annex 1: presentation of the new draft and interpretation, gmp experts
Eudralex Vol .4 Annex 1: presentation of the new draft and interpretation, gmp experts
Empower 3 Quickstart, Basic User Training, Eschborn
Process- and cleaning validation, gmp Experts GmbH, Karlsruhe
Supplier audits, gmp Experts GmbH, Darmstadt
Audit and Self inspections, PCS Seminar, Heidelberg
GMP Quality Agreements, Forum Institut für Management GmbH, Frankfurt am Main
Impact of new regulations on excipient suppliers and pharmaceutical industry, IPEC Europe
Supplier qualification, Training as GMP-Auditor, gmp Experts GmbH, Aarau, Switzerland
GMP Documentation, PCS Seminar, Karlsruhe
GMP training seminar at Bayer Pharma AG, Berlin