Beschreibung
For our client, an international biopharmaceutical company, we are looking for a
Process and Technical Operations Validation Specialist (m/f)
Reference: -en
Start: 02/15
Duration: 6 MM
Place: in West Switzerland
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Lead and participate in the development and assessment of strategies, execution and reporting of validation activities following equipment or process changes
- Write, review and approve OQ, DV, PQ and PPQ protocols, strategies and reports for CIP (Clean-in-place) validation
- Maintain and develop expertise in CIP/COP validation
- Responsibility for the planning of revalidation activities
- Provide technical support, quality, engineering and manufacturing organisations (lead or support deviations or investigations, root cause analysis, CAPA definition and implementation)
- Participate in internal or external assessments and support processes with timely closure of observations and audit items
- Lead or support CIP/COP training for the manufacturing organisation, following the cGMP and GDP and other applicable guidelines
Your qualifications
- Technical background in biotechnology, the pharmaceutical industry, process engineering, chemistry or equivalent
- Proven relevant experience in the field of operational CIP (Clean-in-place) validation
- Fluency in English (both spoken and written), preferably also in French
Skills:
- Qualification/validation specialist
Keywords: Spezialist Validierung und Qualifizierung