QA manufacturing senior specialist
We have an opportunity for a Quality/Manufacturing specialist to join a project on 12 months contract to support pilot plant activities.
• Developing and maintaining policies and SOPs with regard to qualification of equipment and premises/facilities
• Advice Line Units with regard to qualification plans and reports.
• Control and approve related documents
• QA representative for new initiatives commercial, development of new tools, processes, Quality Initiatives, QM/QDs implementation, Quality Plans, SQRA, qualification and facility upgrade activities, IT validation projects)
• Support line functions during their qualification/validation efforts
• Check deviations risen from qualification activities and execute their follow up
• Interpretation of new regulatory requirements, evaluate their impact and coordinate implementation
• Approving change requests and release of the corresponding equipment/facilities and IT-Systems
• Control that the related service providers and suppliers appropriately comply with corresponding set of Standards
• Carrying out internal audits as well as vendor audits, in a supportive auditor role when needed
• Approving documents prepared by line units during qualification/validation exercises
• Approving deviations associated with qualification/validation and analytical/IT-Systems
• Review and/ or approve as applicable operational SOPs and GxP-concepts, Validation Master Plan, as delegated • Release of consumables when required.
• Represent the Plant in inspections, audits, and local and global initiatives.
• Perform inspections and audits as required
* Chemist or Pharmacist (MSc or Ph.D. from accredited Technical University) or appropriate education and experience in pharmaceutical industry
• English and German Language in speaking and writing
• Experience in GMP manufacturing environment within the pharmaceutical industry
Please send your CV to Beata Klecz on
Michael Bailey International is acting as an Employment Business in relation to this vacancy.