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QA Documentation Specialist

Amsterdam
As QA Documentation Specialist you will support the QPs in their approvals. You will work as the first person in a new team of Eurofins PSS on this location with a focus on working on Alzheimer disease.

Bedrijfsnaam

Our client is a scientific insourcing service provider in the pharmaceutical industry.

Locatie

Amsterdam omgeving

Functie omschrijving

  • Pull data, and review production batch records of DS and DP for accuracy and completeness
  • Maintain batch manufacturing record files according to storage procedures
  • Store, manage and track company documentation in MYCIM or Vault (DS/DP/IMPs for EU&CH)
  • Ensure compliance to GMP
  • Ensure that all necessary steps have been completed under accepted pharmaceutical quality systems to assure compliance of the batch records with GMP
  • Working with other departments and communicate internally and externally effectively

Profiel kandidaat

  • Bachelor of Science
  • Relevant experience in a pharmaceutical environment and good knowledge of GMP
  • You possess extensive knowledge of Quality Assurance Documentation and administration
  • Computer proficiency (Word and Excel), experience in MYCIM and Vault strongly preferred
  • Excellent interpersonal, organizational, written and oral communication skills
  • You are well organized and you can meet strict deadlines and perform under pressure in a fast-paced environment
  • You are able to work independently as well as collaboratively in a team setting with peers and other departments in a cross functional setting
  • You are a self-starter, detail oriented and able to prioritize and balance both workload and timelines
  • You have a professional proficiency in English.

Bedrijfsprofiel

Our client is a scientific insourcing service provider in the pharmaceutical industry.
It is part of the internationally operating organisation. With more than 400 labs and more than 45,000 colleagues, they are world leaders in the field of analyses for BioPharma, Food, Environment and Clinical Diagnostics.

You will work in an international environment, within an enthusiastic team and for an organization with sufficient space to develop further. Teamwork is extremely important and having fun in what you do is also part of that! The monthly team lunches, team events and awarding awards to colleagues are an example of this.

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