Job Description

Project:

For our pharmaceutical client based in Basel, we are looking for a Technical QA Manager Annex 1 Project (m/f/d)

Background:

Our IMP Quality Qualification/Validation team plays a central role in ensuring GMP compliance for equipment and systems used in the manufacture of investigational medicinal products (IMPs) in Basel and Kaiseraugst. As part of the Annex 1 project in our sterile filling department, we are seeking support for the (re)qualification of our existing and new equipment as soon as possible.

The perfect candidate

has several years of experience in Quality Assurance and ideally experience with Veeva QMS and relevant qualification/validation systems, as well as experience with Eudralex Vol. 4 Annex 1 requirements.

Main tasks and responsibilities:

QA oversight of qualification and validation activities for GMP-relevant equipment and systems in sterile filling QA oversight of CSV systems Supporting the implementation of data integrity requirements Reviewing and approving GMP documents (e.g., qualification plans, reports, change and deviation management, CAPAs, SOPs, risk analyses) Handling deviations and changes Collaborating with stakeholders and contributing to the achievement of common goals Representing the area of ??responsibility during inspections by health authorities and internal audits.

Must-haves:

Academic degree in engineering, chemistry, life sciences, 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 medicinal products 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 have:

Experience with Veeva QMS, eVAL and ELVIS

Reference No

.: 924620

Role:

Technical QA Manager Annex 1 Project (m/f/d)

Industry

: Pharmaceuticals

Location

: Basel

Workload

: 100%

Start

: ASAP

Duration

: 7 months

Application deadline

: December 8, 2025

Job Type: 100%

Work Location: On the road