vacature kwaliteit

Quality Assurance Specialist

Derks & Derks Detachering

Temporary position for approximately 12 months at a pharmaceutical company

Offer
  • diverse job within a pharmaceutical company
  • interesting position to use your skills and knowledge in Quality Assurance
  • temporary contract with the possibility to extend
Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located at Leiden but with a tight line to the other affiliates. In order to give extra support to a project the organisation is searching for a Quality Assurance Specialist.

Position

As a Quality Assurance Specialist, you will collaborate in further setup, maintenance and implementation of the pharmaceutical quality management system as well as performance of several measures to secure the quality management of the affiliate and its third parties.

In this role you need to act as a deputy Responsible Person as defined in EU GDP Guideline 2013/C343/01. You will perform quality assurance activities on behalf of the affiliate in its capacity as wholesaler and Marketing Authorisation Holder. You will be responsible to ensure all products, personnel and third parties conform to local, European and company quality assurance requirements. You need to ensure implementation and maintenance of a Quality Management System, which need to be compliant with EU GDP Guidelines, local legislation and corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and Marketing Authorisation Holder activities undertaken by or on behalf of the affiliate. You need to maintain independence with regards to QA decision making within the affiliate. You will work in a team and report to the manager of the department.

Profile
  • Bachelor’s degree in health science or related subject
  • minimum 2 years of experience in the pharmaceutical industry
  • experience in Quality is an advantage
  • experience in handling regulatory interfaces such as inspections and audits are an advantage
  • good understanding of the EU GDP, EU GMP and QMS
  • ability to communicate and negotiate with peers
  • understanding of local and European regulatory environment
  • good organizational, coordination, diplomatic, negotiation, presentation and communications skills
  • precise, rigorous and reliable with an analytical mind
  • good decision-making skills
  • computer literacy
  • fluent in written and spoken English
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-022-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

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