Quality Assurance Specialist

Description

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.