Randstad Professionals is currently looking for a Quality Assurance / Quality System Specialist (German speaker) who will be assigned an interesting challenge for a major client based in Berne. This contract is an unique opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health).
The initial assignment will start immediately and will last until February 2019.
Position: QA specialist / Quality System Specialist
Description of Position
* Maintenance and continuous improvement of the site's Quality Systems
* Management of supplier / contractors (e.g. qualification, monitoring, auditing, SLA / TQA) regarding quality aspects in order to ensure compliance to contracts, cGMP/GDP standards and requirements set by regulatory authorities.
* 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
* Approval or blocking of 3rd party suppliers (in collaboration with Procurement department)
* 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 of VPAD in line with the phase-out project
* Approval / blocking of suppliers
* 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
* Ensure cGMP/GDP compliance of 3rd party suppliers / contractors
* Close collaboration / open communication with all interfaces
* Up-to-date approved supplier list
* Up-to-date supplier files ('Auftragnehmerdossiers')
* Contracts in place with suppliers, where applicable
* Achievement of individual as well as group Goals & Objectives
* Sound 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
If you are interested for this great role, don't hesitate to send your application or to contact me directly. I am looking forward to shraring more details with you.
Consultant Life Sciences
T +41 58 201 55 55