...validation, packaging or related field
Knowledge / Skills / Abilities:
~ Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
~ Knowledge...
Empfohlen
...years of work experience in a GMP environment
Knowledge / Skills / Abilities:
Good knowledge and interpretation of cGMP and regulations applicable to the Quality Control environment.
Good knowledge of analytical method transfer and analytical method validation...
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Soforteinstellung
...recommendations for continuous improvements in Quality systems as required.
Contributes of regular reporting of quality processes metrics.
Ensures that all regulations concerning product security and all established working methods are respected within the area of...
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Schichtarbeit
Spätschicht
...validation, packaging or related field
Knowledge / Skills / Abilities:
Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and CAMP
Experienced...
Empfohlen
...microbiological testing is performed in compliance with the site’s Quality Management Systems (QMS), the cGMP, the applicable laws, regulations, and standards, and in compliance with the Product’s Dossier managed by the Customer.
The position holder is responsible,...
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