- Review and Approve Deviations and CAPAs in Quality Assurance Role (initial and final classification, review as Quality Representative, approval)
- Perform regular meetings to support the Investigation Leads of the operational departments
- Assure ongoing compliance with the customers requirements
- Assure ongoing compliance with quality and industry
- regulatory requirements
- Develop and implement improvements of the deviation respectively the CAPA site procedure
- D. /M.Sc. /B.Sc. in Microbiology, Biology, Pharmacy, or other related sciences.
- At least 10 years’ experience in Human Health quality assurance, production or quality control
- Experience in EMA and/or FDA regulated environment and how to prepare for an inspection
- Subject Matter Expert in Deviation and CAPA management
- Proven ability to author GMP documentation correctly at first attempt
- Excellent teamwork skills
- Excellent communication and training skills
- Project experience and ability to work independently (self-starter)
- Ability to operate in a global environment with a high level of diversity and different cultures.
- Language: Fluent in German and English.
Verfügbarkeit: 4-5 Tage / Woche
On-site Support: 100%