Quality Engineering within the broader QA/RA function plays a key role in ensuring GMP compliance across production, analytical, and infrastructure systems, while supporting the continued growth and innovation of PM Group’s Life Sciences portfolio. To reinforce our high-performing team, we are currently seeking a motivated and technically strong QA Engineering Specialist (m/f/d).
:As a member of the QA Engineering team, you will play a central role in the lifecycle management of our GMP-relevant facilities and systems:
Ensure GMP-compliant operation of facilities throughout their entire lifecycle, including requalification, maintenance, change control, and deviation management
Contribute to qualification and validation projects (equipment, infrastructure, processes) and provide QA expert evaluation
Create, review, and approve GMP-relevant documents (e.g., URS, qualification packages, SOPs, logbooks)
Actively report and provide expert advice to stakeholders on technical and quality-related issues
Support regulatory authority inspections and customer audits, and coordinate time-critical activities such as PQR creation or batch document review
Lead smaller projects within QE and contribute to the further development of cross-functional quality processes
Qualifications:
You work precisely, proactively, and responsibly – and you have the skills to succeed in a demanding GMP environment:
Completed bachelor's degree (BSc in Chemistry, Pharmacy, Process Engineering, or comparable field) or equivalent qualification with several years of QA experience
At least 2–3 years of professional experience in a GMP-regulated environment, ideally in qualification/validation or technical QA processes
Solid GMP knowledge of Switzerland and EU, and confident creation and evaluation of GMP-relevant documents
Fluent German skills (C1) and good English skills (B2), both spoken and written
Proficient use of MS Office, ERP/MES/QM systems, and digital communication and planning tools
Analytical and structured working style, high solution orientation, strong communication skills, and professional collaboration with internal and external stakeholders
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