For our client in Stein we are looking for a QA Pilot plant senior specialist for a 11-month project.
Duration: 2018-02-01 bis 2018-12-31
* Chemist or Pharmacist (MSc or Ph.D. from accredited Technical University) or appropriate education and experience in pharmaceutical industry
* English and local language, speaking and writing
* Experience in GMP manufacturing environment within the pharmaceutical industry
* Developing and maintaining policies and SOPs with regard to qualification of equipment and premises/facilities
* Advice Line Units (first line support to Stein Pilot Plant) with regard to qualification plans and reports.
* Control and approve related documents
* QA representative for new initiatives in Stein Pilot Plant (e.g. Pilot Plant go 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 from Head QA Stein Pilot Plant.
* Release of consumables when required.
* Represent Stein Pilot Plant QA in inspections, audits, and local and global initiatives.
* Perform inspections and audits as required
For further details please contact Beata Arciszewska:
Harvey Nash AG
+41 44 296 8844