QA Manager

Vor 3 Tagen

Basel, Schweiz Personal Contact Basel AG Vollzeit

Personal Contact vermittelt und verleiht seit über 25 Jahren erfolgreich qualifiziertes Personal in den Bereichen Industrie, Pharma, Technik und Gewerbe.

Mit Fachkompetenz, Menschlichkeit und Engagement bietet Personal Contact lückenlose Dienstleistungen an, welche den höchsten qualitativen Ansprüchen des Personalwesens entsprechen.

Für unseren Kunden, ein Schweizer Pharmaunternehmen suchen wir per sofort oder Vereinbarung eine/n QA Manager (QA Compliance) 100% (M/F/d)

Aufgaben

**Major Accountabilities**:

- Create, review and approval of SOP to support continuous improvement of internal requirements to ensure GMP compliance
- Process, track and ensure timely completion of changes with and without regulatory impact
- Train employees in change control procedure
- Process, track and ensure timely completion of deviations and associated corrective and preventive actions
- Prepare, review and approval of annual product quality review
- Compilation and analysis of batch specific data from SAP, LIMS, TrackWise®, PAS-X and contract database
- Lead and participate in Health Authority inspections and customer audits, including processing related CAPAs
- Planning and performing internal audits
- Review and approval of documents from the areas of process transfer/validation, equipment, infrastructure qualification and technical changes
- Review and approval of documents from the area of cleaning validation and environmental monitoring
- Review and approval of analytical methods and validation
- Implementation of quality improvement projects
- Compiling and reporting corporate and customer-specific KPI

Qualifikation
- Education in pharmacy, natural sciences or equivalent
- Sufficient experience with pharmaceutical technology or experience in the pharmaceutical industry
- Several years of experience in the GMP regulated environment, preferably with processes involved in manufacturing, Quality (QA and QC), validation
- Good communication skills and team-oriented personality with great initiative and a strong skills in coordinating cross-department teams and negotiation
- Skilled in quality risk management
- Reliable and careful work methods with a clear view of priorities
- Well organized and quality oriented
- Very good knowledge of English and German (oral and written)

Wir freuen uns auf Ihre vollständige Bewerbung.

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