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Tech. Services Manufacturing Associate - API (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Engineering
Projektbeschreibung
REFERENZNUMMER:
275930/11
IHRE AUFGABEN:
-Provide technical support to contract manufacturers and oversight for established active pharmaceutical ingredients (API) managed by the Local Operations/API organization, ensuring a reliable supply of quality products at minimum cost
-Work with cross-functional groups to troubleshoot issues arising at Contract Manufacturing sites, including but not limited to deviations
-Maintain an appropriate presence during manufacturing
-Review process and product data for adverse trends; assess and understand process capability
-Conduct/support process validation
-Review and/or approve Annual Product Quality Reviews (APQR)
IHRE QUALIFIKATIONEN:
-Advanced Science (e.g. Engineering, Chemistry, Biochemistry) degree and/or Bachelor of Science degree with relevant work experience
-Prior relevant pharmaceutical manufacturing experience, specifically drug substance, API
-Understanding of cGMP requirements for drug substance and drug product manufacturing
-Strong problem solving skills, including strategic and creative thinking
-Strong interpersonal skills
-Fluency in English, German skills are nice to have
WEITERE QUALIFIKATIONEN:
Quality manager
275930/11
IHRE AUFGABEN:
-Provide technical support to contract manufacturers and oversight for established active pharmaceutical ingredients (API) managed by the Local Operations/API organization, ensuring a reliable supply of quality products at minimum cost
-Work with cross-functional groups to troubleshoot issues arising at Contract Manufacturing sites, including but not limited to deviations
-Maintain an appropriate presence during manufacturing
-Review process and product data for adverse trends; assess and understand process capability
-Conduct/support process validation
-Review and/or approve Annual Product Quality Reviews (APQR)
IHRE QUALIFIKATIONEN:
-Advanced Science (e.g. Engineering, Chemistry, Biochemistry) degree and/or Bachelor of Science degree with relevant work experience
-Prior relevant pharmaceutical manufacturing experience, specifically drug substance, API
-Understanding of cGMP requirements for drug substance and drug product manufacturing
-Strong problem solving skills, including strategic and creative thinking
-Strong interpersonal skills
-Fluency in English, German skills are nice to have
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges