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Randstad (Schweiz) AG

Quality Manager

100% Führungsposition 19.02.2019
Quality Manager

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  

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