Quality Assurance Associate

Become the Quality Assurance Associate of this pharmaceuticals company and manage the GDP regulated activities in the Netherlands. Ensure the compliance of this company's requirements and local regulations. Also become responsible for ensuring Good Distribution Practice. Does this sound like the opportunity you have been looking for?

Apply today.

Job Description

• Ensuring that a quality management system is implemented and maintained (incl. quality riskmanagement, corrective and preventative actions ,CAPAs, to address deviations, change control, measurement of performance indicators and management review
• Ensuring that initial and continuous training programmes are implemented and maintained
• Coordinating and promptly performing any recall operations for medicinal products; The RP is sufficiently supported by other functions to handle all the aspects of the recalls with the appropriate degree of urgency
• Ensuring that suppliers and customers are approved, and carry out due diligence checks
• Ensuring that relevant customer complaints are dealt with effectively
• Approving any subcontracted activities which may impact on GDP 
• Ensuring that self-inspections are performed at appropriate regular intervals
• Arranged programme and necessary corrective measures are put in place
• Keeping appropriate records of any delegated duties
• Deciding on the final disposition of returned, rejected, recalled or falsified products
• Approving any returns to saleable stock
• Ensuring that any additional requirements imposed on certain products by national law are adhered to
• The RP acts as contact person for the Dutch Health authority
• The RP works closely together with the DSO, Medical Director, Financial Director and other relevant stakeholders
• The RP should carry out his/her duties in such a way as to ensure that the company can demonstrate GDP compliance and that public service obligations are met

Job Requirements

University Degree MSc in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology

GDP training courses, demonstrable by certificates

Specific knowledge of Cold Chain Management and transport validation

Specific knowledge with respect to wholesale activities of human medicines

At least 2 years of practical experience in storage and distribution activities of medicines

Experience in a similar position at a local affiliate in the pharmaceutical industry is an advantage