About this role

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: