About the role

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).

Responsibilities:

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