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QA Site Manager Warehousing (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering
Projektbeschreibung
REFERENZNUMMER:
266478/11
IHRE AUFGABEN:
-Provide Quality oversight for GxP operations for drug substances (storing, sampling, dispensing)
-Ensure cGMP Compliance in the area/dept. of Small Molecules External Quality
-Participate in due diligence and GMP compliance audits
-Collaborate with Contract Warehouse to ensure associated CAPAs, complaints, deviations, resolution of investigations and change control assessments
-Develop, negotiate and maintain quality agreement
-Develop and maintain quality risk management plan
-Lead or participate in cross-functional process & quality improvement projects
IHRE QUALIFIKATIONEN:
-University degree (preferably in chemistry, life sciences or engineering)
-Sound and proven experience in the pharmaceutical, biopharmaceutical or a related industry, alternatively equivalent combination of education and experience
-Working knowledge of facility, equipment and process qualification/validation
-Working experience with risk management concepts and tools
-Sound knowledge of cGMPs and relevant international regulatory requirements and experience in Quality Assurance and/or Control
-Fluent English language skills and proficiency in German is desired
-
-Willingness for domestic travels (10%-20%)
WEITERE QUALIFIKATIONEN:
Quality manager
266478/11
IHRE AUFGABEN:
-Provide Quality oversight for GxP operations for drug substances (storing, sampling, dispensing)
-Ensure cGMP Compliance in the area/dept. of Small Molecules External Quality
-Participate in due diligence and GMP compliance audits
-Collaborate with Contract Warehouse to ensure associated CAPAs, complaints, deviations, resolution of investigations and change control assessments
-Develop, negotiate and maintain quality agreement
-Develop and maintain quality risk management plan
-Lead or participate in cross-functional process & quality improvement projects
IHRE QUALIFIKATIONEN:
-University degree (preferably in chemistry, life sciences or engineering)
-Sound and proven experience in the pharmaceutical, biopharmaceutical or a related industry, alternatively equivalent combination of education and experience
-Working knowledge of facility, equipment and process qualification/validation
-Working experience with risk management concepts and tools
-Sound knowledge of cGMPs and relevant international regulatory requirements and experience in Quality Assurance and/or Control
-Fluent English language skills and proficiency in German is desired
-
-Willingness for domestic travels (10%-20%)
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik