QA Pilot Plant Senior Specialist

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

Location: Stein

Workload:100%

Requirements:

. 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

Role Profile:

. 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 (eg 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:
email: (see below)