Quality Assurance Specialist

Quality Assurance Specialist - 8 months contract

Our client, global pharmaceutical company is now looking for a quality assurance specialist to manage tasks related to compliance with current GMP/GDP standards and requirements set by regulatory authorities. The position requires fluency in German language

Duties
. Implementation and support of Quality Improvements (according to Quality Plan) and Quality Processes
. Risk-based qualification, periodical monitoring and re-qualification of 3rd party suppliers/contractors
. Establishment and maintenance of supplier files
. Leading contract/quality agreement activities (in collaboration with Legal department and other affected departments)
. Implementation/alignment of business processes according quality agreements
. Adjustment of supplier management in view of requirements. Appointment of the audit/inspection team (QRA) to audit/inspect 3rd party suppliers/contractors
. Definition of measures for 3rd party suppliers/contractors
. Ensure business processes regarding the QRP team are defined and SOPs are in place

Competencies required.
. Solid experience in Supplier Management
. Profound knowledge of cGMP/GDP regulations and guidelines
. Work experience in a regulated environment (biological/pharmaceutical products, medical devices)
. Strong leadership and negotiation skills
. Excellent writing and speaking skills (German, English)
. Degree in Sciences, Engineering or equivalent
. Proactive, persistent, positive work and can-do attitude

Please send your CV

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