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
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
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