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QA Contamination Prevention Manager
View: 153
Update day: 25-04-2024
Category: Pharmaceutical / Chemical / Biotech
Industry:
Job type: Stage
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Job content
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Bitte bewerben Sie sich direkt online.
Beziehen Sie sich dabei bitte auf die Referenznummer 043-MLRA-180870-28-DE.
QA Contamination Prevention Manager
Ihre Herausforderung
- Ensures that an end-to-end microbial control concept is developed for the biotechnological drug substance manufacturing facilities and is captured in local documents (incl. specifications, SOPs, etc.)
- Supports the Quality Oversight on the activities of the Environmental Monitoring and activities related to the assessment of disinfectants from microbiological expertise point of view
- Writes, Reviews and approves SOPs, deviation reports and change requests associated with the above-mentioned topics
- Supports the preparation and follow-up of customer audits and regulatory inspections; acts as an expert during audits / inspections presenting aspects related to the microbial control and sterility strategies
- Enhances the quality knowledge by following the quality standards and by visiting specific training courses/conferences
Ihre Kompetenz
- University degree (Bachelor, Master or PhD) in pharmacy, engineering, chemistry, or related life sciences discipline, preferably microbiology
- More than 5 years (more than 10 years preferred) of experience in the area of biopharmaceutical manufacturing
- Strong background in cGMPs
- Broad knowledge related to hygiene topics, environmental monitoring, disinfectant testing, microbial control strategies
- Good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies (e.g. US FDA, EMA, etc.).
- Languages: English Fluent and German as an advantage
Ihre Perspektiven
Ihr Kontakt
Bitte bewerben Sie sich direkt online.
Beziehen Sie sich dabei bitte auf die Referenznummer 043-MLRA-180870-28-DE.
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Deadline: 09-06-2024
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