Suchergebnisse: 5 Stellenangebote
...field and/or engineering.
Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects).
Familiarity with GMP requirements, quality procedures and SOP execution.
Previous exposure to any of the commercial MES systems (Rockwell PharmaSuite,...
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...with water treatment plants (purified and water for injection) and external service providers is an advantage.
Strong knowledge of GMP and regulatory qualification requirements.
Excellent writing skills and excellent communication skills with command of German,...
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...pharmaceutical development, IT) or equivalent. Proficient English
Knowledge in quality principles driving drug development such as GMP; understanding of general regulatory and quality expectations.
Strong communication skills, including presentation and scientific/...
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...Role
Major accountabilities:
Maintains overview on projects ongoing at assigned CMOs.
Maintain all assigned companies in a GMP approved status (tracking Third Party Assessment due date and address any need of the prerequisites, audit preparation, Quality Frame...
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...expertise in Mass Spectrometry (ranging from mass confirmation to actual quantitative analysis of impurities and sequencing) is a plus.
• GMP experience and qualification expertise in a GMP environment are assets.
• Strong coordination skills, collaborative spirit, self-...
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