Location: Stein, AG, Switzerland
Start Date: ASAP
Contract Duration: 6 months (with the possibility of extension)
Your Mission:
1. Ensure GMP compliance for critical utilities (e.g., clean water, clean steam, compressed gases), facilities (e.g., HVAC, clean rooms, cold rooms), and process support systems (e.g., autoclave, CIP/SIP) throughout the project management lifecycle from design to qualification, validation, and handover.
2. Oversee the development and execution of CQV (Commissioning, Qualification, and Validation) plans for GMP systems in alignment with Quality policies and Standard Operating Procedures (SOPs).
3. Review and approve CQV plans, protocols, and reports, including project-related CQV documents (e.g., User Requirements Specifications (URS), Factory Acceptance Testing (FAT)/Site Acceptance Testing (SAT), Installation Qualification (IQ)/Operational Qualification (OQ)).
4. Provide quality oversight on CQV documentation and manage related change controls.
5. Lead and guide staff on qualification and validation issues, ensuring smooth execution of tasks.
6. Manage and resolve Quality deviations, changes, and Corrective and Preventive Actions (CAPAs) promptly, while escalating issues when necessary.
Your Background:
1. Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
2. Significant experience in the GMP-regulated pharmaceutical industry, preferably in a Quality Unit role.
3. Proven experience in a QA or Engineering role focused on Clean Utilities related to aseptic fill-finish processes and facilities.
4. Fluency in English; German is an advantage.
What We Offer:
1. An opportunity to work on impactful CAPEX projects within a leading pharmaceutical company.
2. A dynamic role in ensuring the highest standards of GMP compliance.
3. A chance to contribute to a dedicated team in Stein, AG with a focus on innovation and quality.
If you’re a detail-oriented QA professional with expertise in Clean Utilities, we’d love to hear from you! Apply now or reach out directly to Veronika von Mentzer, Recruiter: veronika.nakev@swisslinx.com #J-18808-Ljbffr