Senior QA Expert
Tasks:
- Manage and maintain QA activities to ensure GMP compliance in sterile manufacturing
- Act as the QA single point of contact for assigned activities
- Author, review, and approve quality documents (e.g., SOPs, risk and gap assessments, WIs)
- Coordinate and approve quality records (deviations, CAPAs, change controls, validation/qualification docs) in TrackWise and KNEAT
- Provide QA oversight for manufacturing processes and activities
- Support investigations, including root cause analysis and implementation of action plans
- Contribute to continuous improvement and lean projects
- Support growth projects in alignment with cGMP requirements
- Monitor project progress and ensure effective communication of status
- Collaborate with internal teams and external partners on quality and release strategies
- Participate in audits and inspections (internal and external)
- Define, track, and report quality KPIs
- Maintain and improve QA oversight concepts within manufacturing
- Support QA activities across the drug product network
- Foster a high-performance, collaborative team environment
- Onboard and support new team members
- Deputize QA Team Lead when required
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Qualification:
Master’s or PhD in Chemistry, Biology, Pharmacy, or related field
5–10 years of experience in QA/QC in pharmaceutical manufacturing
Excellent problem-solving, planning, and organizational skills
Strong teamwork and a customer-focused mindset
Strong knowledge of cGMP and regulatory compliance
Fluent in English; German is an advantage
Start: ASAP
Duration: 8 months
Capacity: 5 days per week
Location: Stein
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