Quality Specialist

Functie omschrijving Quality Specialist

For one of our International orientated clients in the Amsterdam area, we are seeking for a Quality specialist to support the Quality Manager

  • Responsible for the development, maintenance and continuous improvement of the
  • Quality Management system to meet Company, Customer and Regulatory agreed expectations.
  • Provide hands-on ownership for the various elements of the quality system to ensure successful performance during third-party audits and regulatory inspections.
  • Assist with Quality investigations.
  • Provide support to internal functions in the application, maintenance and improvement of quality systems and department specific procedures.
  • Lead root cause analysis and develop associated CAPA to prevent recurrence and ensure completion of effectiveness checks.
  • Initiate updates and creation of new functional SOPs as required.
  • Serves as Quality representative for regulatory inspections as needed.
  • Work closely with the Global QA Manager and Global Quality division where required.
  • Identify efficiency and quality improvements in own area of responsibility and implement required changes.
  • Participate in customer and supplier audits.
  • Support the division quality team with REACH assessments and understanding of European regulations such as RoHS, CLP.
  • Responsible for the development of CE dossiers and the certification with the authorities.
  • Liaise with internal departments (e.g. Supply Chain, Operations, Customer service).
  • Responds quickly and effectively to customer complaints and issues.
  • Support the Sales team with requests (e.g. supplier questionnaires, certificates).
  • Support project teams to resolve and permanently fix customer complaints.
  • Support the launch of products of biological and chemical nature providing regulatory assessments and guidance.

Bedrijfsprofiel

  • The QA/RA Specialist is responsible for the development, implementation and maintenance of the Quality Manual.
  • Supports and coordinates the launch of products of biological and chemical nature within the EU with a focus on ensuring regulatory compliance.
  • Deploy Division Quality Management methods and systems
  • Collaborates with Quality and technical teams, Commercial, Division Engineering, and external customers, suppliers, and contract manufacturers to support on quality related matters.

Sollicitatieprocedure

Joost Cornelissen + 31 20 751 33 25


Solliciteren

Wij vragen van de Quality Specialist

  • Bachelor/Master degree in Life Sciences, Pharmacy, Biotechnology or related
  • Knowledge of ISO 9001, and Quality management systems
  • Demonstrated regulatory experience in pharmaceutical industry handling biological products incl. GMO, stem cell, human and animal tissue
  • Working knowledge of Quality management systems and applicable laws and regulations
  • Excellent communications skills, accurate and solution focused
  • High level of spoken and written English

Locatie

Amsterdam

Naam organisatie

Vertrouwelijk

Publish date

14-09-2018

Publish end date

27-09-2018
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