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QA-Officer

Leiden

As a QA Officer you ensure that quality is safeguarded for all (International) clients and products. You like the dynamics of quality assurance in a laboratory and production site with a great diversity of products.

Branche

Farma - Biotech

Locatie

Leiden

Functie omschrijving

As a QA Officer you will:

  • Ensuring GMP compliance incl. management of the quality system
  • Management of opiate samples (incl. quarterly and annual reports)
  • Execution, reporting and follow-up of self-inspections to determine compliance of the organization and its activities with GMP laws and regulations
  • QA Key Management and quality issues
  • Document management and reading training management
  • Checking week analyses, projects, studies and logs for general documentation rules, initials and dates of reviewers
  • Archiving of all GMP documentation and management of this documentation
  • Issue and record lab journals, logs and other QA work

Profiel kandidaat

​​​​​​Your excellent communication skills and your strong personality make it easy to connect with the diverse stakeholders in and outside the organization. You have excellent organizational, facilitating and communication skills. You are able to harvest quality awareness in the company.

Qualifications:

  • A completed MBO or HBO education in Engineering, Science or equivalent technical discipline is required
  • Minimum of 3 years’ experience in a quality environment (GMP/GLP/iso/etc)
  • Working experience in the (bio) pharmaceutical industry or a service laboratory is recommended
  • Flexibility and stress resistance; able to work effectively in a dynamic environment
  • A responsible, pro-active and problem-solving work attitude
  • Good command of the Dutch and English language orally and in writing

Bedrijfsprofiel

Our client is a GMP contract service organization, specialized in chemical and physical testing and is part of an internationally operating Group. The laboratory performs a very diverse package of analyses of raw materials and finished products for a large number of national and international clients within the pharmaceutical industry.

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