Quality Assurance Specialist

2 weken geleden

Assen, Drenthe, Nederland Ardena Voltijd

About Ardena

Ardena is a leading contract research organization serving the pharmaceutical industry. We support pharmaceutical companies from biotech startups to large pharmaceutical corporations in bringing new drugs to the clinic and the market. Our comprehensive and integrated portfolio of services for drug development, manufacturing, and bioanalysis includes laboratory services, such as quantitative and qualitative analyses of all types of drugs and biomarkers in biological matrices.

Our laboratory in Assen is a highly specialized and innovative facility that offers a wide range of bioanalytical services to the global pharmaceutical industry. Our mission is to provide high-quality analyses using techniques such as LC-MS/MS, ligand-binding assays (ELISA), qPCR, and flow cytometry.

We are looking for a Quality Assurance Officer to join our team in Assen, The Netherlands. As a Quality Assurance Officer, you will be responsible for planning, conducting, and reporting of study-, process-, facility-, and supplier qualification audits. You will also monitor and follow up on audit finding responses, facilitate regulatory inspections and sponsor audits, and maintain the quality management system.

Your Key Responsibilities

  • Planning, conduct, and reporting of study-, process-, facility-, and supplier qualification audits
  • Monitoring and follow-up on audit finding responses
  • Facilitating regulatory inspections and sponsor audits
  • Involvement in quality improvement projects and activities
  • Maintenance of the quality management system
  • Training and guidance on GLP requirements and best practices

Your Profile

  • A thorough understanding of and experience with GLP quality management concepts and principles, 21CFRp11 regulation, and GAMP guidelines
  • Takes initiative and has a persistent and pro-active can-do attitude
  • Strong networker with good negotiation, problem-solving, and analytical skills
  • Accurate, proactive, critical, decisive, and flexible
  • Works well with others (Team Player), including internal teams and external stakeholders
  • Bachelor's degree or equivalent experience

What We Offer

  • Salary range: 3000,- to 4500,- gross per month (based on a 40-hour workweek)
  • A true learning environment where you will have the ability to grow your skills
  • A dynamic working environment with friendly and enthusiastic colleagues
  • A company culture with open communication, where employee well-being is highly valued
  • An attractive remuneration package
  • Flexible working hours

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