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QA Manager - Inspection Management


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Our customer, an international pharmaceutical company with headquarters in Basel, is looking for a

QA Manager - Inspection Management

As Quality Manager you support inspections as part of the compliance support group of Roche Kaiseraugst including the Drug Product Manufacturing Roche Basel.

Your responsibilities include primarily:

• Main Responsibility for planning, coordination of self-inspections in Basel and Kaiseraugst
• Performing self-inspections at Drug Product Manufacturing Basel
• Responsibility for own implementation, documentation and tracking of self-inspections
• Co-ordination, documentation and tracking of health authority and customer inspections
• Ensuring the readiness inspection at the site regarding regulatory requirements


General tasks:

• Provide Production and Quality departments input to the review and approval of manufacturing and Quality related documents
• Review of GMP documents as requested
• Review current health authority observations and warning letters to monitor the inspection climate.
• Participate in post-inspection activities including observation response process and commitment follow-up and tracking
• Implement Inspection Readiness procedures and ensure inspection readiness for Kaiseraugst and Basel parenterals production
• Conduct "Inspection Readiness" training for managers, groups and SMEs
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance


Qualifications:

• University degree in pharmacy, microbiology, chemistry or biochemistry or a similar training (e.g., Quality Engineer)
• Several years of professional experience in the pharmaceutical parenterals production and/ or quality assurance and / or Quality Management
• Sound knowledge of international GMP experience
• In-depth knowledge of FDA specific regulatory requirements
• In-depth knowledge in Inspection Readiness Procedures
• In-depth Auditing experience
• Team player and a communicative personality
• Assertiveness and initiative is a must
• Thorough and independent way of working
• In-depth knowledge of documentation systems and computer skills.
• Very good oral and written English skills


Assignment start: As soon as possible
Contract duration: 31.12.2014
Service level: 100%
Location: Kaiseraugst
If you are interested in this position and bring the required experiences and skills, please apply online or send your full application (CV, copies of your diploma and reference letters) to Ms Claudia Hudson ().
Region: Basel
Vertragsart: Befristet
Kategorie: Qualitätswesen
Veröffentlicht am: 20.10.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1404-7952
Abteilung: Kelly Scientific Resources ist eine Fachabteilung von Kelly Services: hier werden Sie von Experten im Bereich Scientific betreut.
Kelly Services (Schweiz) AG ist einer der führenden Dienstleister für innovative Personallösungen: Unsere massgeschneiderten Lösungen decken den Bereich Personalwesen, die Rekrutierung und auch Workforce Management ab. Für Personalberatung und Outsourcing liefern wir Lösungen im Bereich Rekrutierung und Mediation für Dauer- und Temporärstellen in allen Funktionen und Hierarchiestufen. In der Schweiz beschäftigt Kelly Services über 200 Mitarbeitende in über 40 Filialen und Fachabteilungen.Link megjelenítése" width="0" height="0" />
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