For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Technical QA Manager to support the (re)qualification of existing and new equipment as a part of the Annex 1 project in their sterile filling facility.
General Information:
- Start date: ASAP
- Duration: project planned until July 2026
- Contract: temporary contract via Randstad
- Workplace: Basel
- Workload: 100%
- Remote/Home Office: on-site presence required, with the possibility of working from home by arrangement
- Working hours: Standard
- Team: 16 QA Managers
- Department: IMP Quality
Tasks & Responsibilities:
- QA oversight of qualification and validation activities for GMP-relevant equipment and systems in sterile filling
- QA oversight of CSV systems
- Support in implementing data integrity requirements
- Review and approval of GMP documents (e.g., qualification plans, reports, change and deviation management, CAPAs, SOPs, risk analyses)
- Handling deviations and changes
- Collaboration with stakeholders and contributing to the achievement of shared objectives
- Representing the area of ??responsibility during inspections by health authorities and internal audits
... Must Haves:
- Academic degree in Engineering, Chemistry, Life Science, Pharmacy, or equivalent
- Minimum 5 years of experience in the pharmaceutical industry
- Minimum 2 years of experience in Quality Assurance
- Experience in equipment qualification and validation in the manufacture of sterile pharmaceuticals
- Understanding of current Data Integrity (DI) requirements
- Knowledge of global quality and GMP requirements
- Strong team player with excellent communication and influence skills
- Proven success in health authority inspections and internal GMP audits
- Fluent in German and English (spoken and written)
Nice to Haves:
- Experience with Veeva QMS, eVAL, and ELVIS
Sounds interesting? Apply Now! We look forward to receiving your application.
Application Submission Deadline: 09.12.2025
