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Bulk manufacturing support staff

Ludwigshafen am Rhein, Germany Req ID 2207996 Category Research and Development Division AbbVie
  • The Drug Product Pilot Plants (DPPP) division in Ludwigshafen is responsible for the production of oral and parallel clinical investigational medicinal products.  The Bulk Manufacturing Support  group supports manufacturing in terms  of material procurement and manufacturing documentation.  You are a member of the "Batch Documentation" team and share the work with another colleague. Their main interfaces are the local manufacturing groups and the local and global development units.

    Description main tasks:

  • Timely preparation of manufacturing instructions and their equipment for the production of oral and parenteral clinical investigational medicinal products based on development documents and in accordance with regulatory requirements
  • Provision of GMP-compliant authorized manufacturing protocols
  • Creation of product- and batch-related orders for production in SAP
  • Conceptual work in cooperation with local and global colleagues from the manufacturing and development units to optimize the manufacturing documentation, its basic documents and associated processes
  • Creation and revision of work instructions
  • Preparation of official audits
  • Completed scientific studies or several years of experience in a comparable position in pharmaceutical manufacturing
  • Very good knowledge of pharmaceutical processes
  • Very good knowledge of regulatory requirements for drug manufacturing
  • Experience in a GMP-regulated environment of pharmaceutical development/manufacturing
  • Very good knowledge of MS-Word
  • Good command of spoken and written English
  • SAP knowledge is an advantage
  • Very good problem-solving, communication and team skills
  • High level of commitment and flexibility
Travel: No
Job Type: Experienced
Schedule: Full-time

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  • Research and Development, Ludwigshafen am Rhein, Rhineland-Palatinate, GermanyRemove

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