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QC Expert (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
REFERENZNUMMER:
359302/11
IHRE AUFGABEN:
-Main contact for QA/QC organisation and customers e.g. Process Unit, SCM, RegCMC, PhQA, TRD
-Management of QA/QC processes and procedures, product responsibility, validation and qualification, monitoring
-Maintain and build contacts with external experts, e.g. GQO, TRD, RegCMC, SCM, HSE etc. and ensure fast and direct communication channels
-Provide scientific and technical expertise on QA/QC procedures within ChemOps CH and to other organizations
-Maintain and adhere to cGMP, SOPs, Rolling Review, CAPA
-Prepare, participate in and conduct authority inspections and audits
-Ensure uniform GMP standards through regular exchange with central QA function
-Initiate revision, validation and improvement of GMP documents e.g. testing monographs, SOPs, qualification and validation documents
-Manage investigations regarding product quality (e.g. OOS/OOE, deviations, customer complaints)
-Provide input to health authority requests and maintain state-of-the-art knowledge of Health Authority requirements, trends, technologies, processes and systems
IHRE QUALIFIKATIONEN:
-University or academic degree in Chemistry, Biology, Pharmacy or equivalent
-German and English skills
-Experience in chemical/pharmaceutical industry is of advantage
-General IT-knowledge
WEITERE QUALIFIKATIONEN:
Quality manager
359302/11
IHRE AUFGABEN:
-Main contact for QA/QC organisation and customers e.g. Process Unit, SCM, RegCMC, PhQA, TRD
-Management of QA/QC processes and procedures, product responsibility, validation and qualification, monitoring
-Maintain and build contacts with external experts, e.g. GQO, TRD, RegCMC, SCM, HSE etc. and ensure fast and direct communication channels
-Provide scientific and technical expertise on QA/QC procedures within ChemOps CH and to other organizations
-Maintain and adhere to cGMP, SOPs, Rolling Review, CAPA
-Prepare, participate in and conduct authority inspections and audits
-Ensure uniform GMP standards through regular exchange with central QA function
-Initiate revision, validation and improvement of GMP documents e.g. testing monographs, SOPs, qualification and validation documents
-Manage investigations regarding product quality (e.g. OOS/OOE, deviations, customer complaints)
-Provide input to health authority requests and maintain state-of-the-art knowledge of Health Authority requirements, trends, technologies, processes and systems
IHRE QUALIFIKATIONEN:
-University or academic degree in Chemistry, Biology, Pharmacy or equivalent
-German and English skills
-Experience in chemical/pharmaceutical industry is of advantage
-General IT-knowledge
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges