The Quality Assurance Specialist plays a central role in ensuring quality, compliance, and regulatory excellence in a GMP-controlled environment. The position contributes directly to business success by reviewing and approving key quality documentation and supporting investigations, CAPAs, and audits. Working closely with internal teams and customers, the role acts as a trusted QA partner in daily operations. It offers broad exposure across quality topics, strong stakeholder interaction, and the opportunity to actively shape compliant processes in a dynamic environment.
1. Review and approval of SOPs, protocols, reports, Certificate of Analysis and other quality documents
2. Support quality investigation of deviations and Out of Specification (OOS)
3. Maintenance, recording and processing of corrective and preventive measures (CAPA)
4. Performing internal audits
5. Organization and management of customer audits, and inspections
6. Apply and interpret audit and compliance requirements
7. Act as QA point of contact for customers
8. Support for GMP training
9. Scientific education (Master degree) in analytical chemistry/ biochemistry/ life science
10. Multi-year, industrial work experience of 5 years minimum in the analytical-pharmaceutical environment preferably experience in QA
11. Strong problem-solving skills to meet business objectives
12. Excellent interpersonal skills and teamwork spirit
13. Ability to collaborate in a dynamic, cross-functional matrix environment
14. Broad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph.
15. Solid background in data integrity and computerized systems risk assessment and project support
16. Experience as an auditor is an asset
17. Fluency in English, German is an asset