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Quality Assurance Officer

Bio-Pharma/Biotech - Dutch Limburg

Our client is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. They harnesse science and technology to create products that support safer and healthier living and that enhance the overall quality of life.

To support the development of the company in Dutch Limburg, we are looking for a (m/f):

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Quality Assurance Officer

Cell Culture

You are responsible for planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility.

Responsibilities:
  • Plan and execute quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation.
  • Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests).
  • Monitor compliance with all applicable GMP and safety standards.
  • Prepare data for trending (QRB, Annual Product Review) and support internal and external audits.
  • Handle, distribute and archive controlled documents.
  • Support the Qualified Person in his role, including audits and quality training.
Profile:
  • Bachelor’s or Master degree in Biotechnology, Chemistry or any related field.
  • 2 years of experience with GMP standard in industrial environment.
  • Excellent technical writing, communication, and organizational skills.
  • Proactive thinking team-player, accurate, attentive to detail, flexible, self-organized.
  • Good proficiency in English.
Offer:
  • A challenging position within a high-potential innovative biotech company.
  • To work in a dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.
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