quality manager in Bern

posted
contact
Olivier Worch, Basel Professionals Health Care & Life Sciences
job type
temporary
apply now

job details

posted
location
bern
sector
Life Sciences
job type
temporary
reference number
11120
contact
olivier worch, basel professionals health care & life sciences
phone
058 201 55 50
apply now

job description

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