QA manufacturing senior specialist

Company: Michael Bailey Associates - Zurich
Job type: Other

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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