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.
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
• 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
Competencies
• 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
Responsibilities
• 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
Performance measurement
• 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
Mandatory;
• 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.
Olivier Worch
Consultant Life Sciences
T +41 58 201 55 55
olivier.worch@ch.randstad.com