Technical QA Manager (Annex 1 Project) (m/w/d)
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
* Duration: Project planned until July 2026
* Contract: Temporary contract via Randstad
* Workplace: Basel
* 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
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Quality Assurance, Engineering, and Project Management
Industries
Staffing and Recruiting and Pharmaceutical Manufacturing
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