Description
Senior Laboratory Professional Sen QA/QC Professional / (Biologics QA)Für unseren Kunden, ein Marktführer in der Pharmazeutischen Industrie, bin ich auf der Suche nach einem "Senior Laboratory Professional"
- Projektdauer:
- Location: Stein Schweiz
- Business Unit: Sterile QA (Biologics)
Job purpose:
- The QA for QC Senior Professional (postgraduate) is a member of the QA for QC operations team.
- The team owns the quality aspects of all QC release and monitoring relevant processes.
- She provides QA oversight for all GMP related QC activities in Stein Steriles/BTDM.
- Main focus lies on the product specific release related analytical activities within those labs and furthermore support additional non release related analytical activities (e.g. microbiological monitoring activities of utilities and stability activities)
Core activities of the QA for QC Team include:
- Data Integritiy/Life Cycle of Lab Equipment
- QA release of analytical results (generation of CoA based on respective product specific Testing Monograph, compendial method), i.e. Usage Decision TM lifecycle management
- Approval of analytical deviations and OOS/OOE records
- QA oversight of QC laboratories
- QA support of stability group/activities
Main Tasks:
- Major accountability to support QA Professional and QA Specialist in daily operational work
- Usage Decision /technical release of analytical results
- First point of contact for internal local customers (e.g ESO, Supply chain; QC analyst
- Review/Approval Inspection Instruction
- Review/Approval Lab Documents/Journals
- Lab Oversight
- Audit and inspection support
Candidate Profile:
Technical education with 4-7 years relevant experiences or
BSc / MSc Graduate with 0-4 years working experiences
Languages:
German: fluently spoken/written
English: very good knowledge spoken/written
Sollten Sie Interesse an dieser oder ähnlichen Herausforderungen haben, bitte wenden Sie sich per Email an mich.
Beste Grüsse
Sabina Keel
Senior Candidate Relationship Manager
Medical Devices Pharma & Biotech
Real Zurich, 8001, Switzerland