Technical QA Manager Annex 1 Project (m/f/d) - Quality Assurance/ Pharmaceutical Industry/ Equipment Qualification/ Validation/ Data Integrity/ GMP/ German/ English
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
If this position has sparked your interest, please send us your complete application. If this position isn't quite the right fit and you'd prefer to be notified about other opportunities, you can also submit your application via this advertisement or to jobs[at]itcag[dot]com.
For more information about our company, our open positions, or our attractive payroll-only program, please contact us at +41 41 760 77 01.
About us
ITech Consult is an ISO 9001:2015 certified Swiss company with branches in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the IT, Life Science, and Engineering sectors.
We offer both temporary staffing and payroll services. These services are free for our candidates, and we also do not charge any additional fees for payroll.
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