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Pharmaceutical Compliance Expert

2 weeks ago

Copenhagen, Copenhagen, Denmark Norgine Full time

We are looking for an experienced Pharmaceutical Compliance Expert to join our quality management team in Copenhagen, Denmark. As a key member of our team, you will maintain Norgine's Nordics quality management systems, ensuring accuracy and quality of records, and managing authorized activities under RP/Quality affiliate oversight.

This 13-month FTC/Maternity Cover role reports directly to the Compliance Manager. You will work closely with colleagues across the organization to identify non-compliance and associated risks, contributing to risk reduction strategies and implementing clearly communicated action plans.

Main Responsibilities:
  1. Maintain Norgine's Nordics quality management systems, focusing on authorized activities and record accuracy.
  2. Act on behalf of the regional cluster to perform delegated duties concerning wholesale distribution licenses, in accordance with EudraLex Vol 4 and European Commission Guidelines.
  3. SUPPORT batch documentation for national administrative releases of products to market, prior to distribution.

You will be responsible for ensuring compliance with regulatory requirements impacting pharmaceutical distribution environments, particularly GMP/GDP guidelines. You must have a scientific degree with a professional qualification and RP status, minimum 3 years relevant pharmaceutical industry experience, and good knowledge of regulatory requirements impacting pharmaceutical and medical device industries.

Main Tasks:
  1. Maintain Norgine's Nordics quality management systems, focusing on authorized activities and record accuracy.
  2. Keep records of delegated duties and activities.
  3. Perform delegated duties on behalf of the regional affiliate network cluster, concerning regional WDA licenses.
  4. Ensure supplier and customer approval.
  5. In case of product recall, promptly execute necessary operations for the regional cluster.
  6. Maintain initial and continuous training programs to assure competency in GDP for the regional cluster.
  7. Perform self-inspections at scheduled intervals, participate in GDP self-inspections for regional clusters, and ensure corrective measures are implemented.
  8. Support data generation and preparation for quality management reviews.
  9. Participate in Regional Inspection readiness activities to ensure adherence to internal and external standards of compliance.
  10. Participate and support external competent authority inspections alongside RP/GDP affiliate teams.
  11. Develop and manage quality documents and KPIs.
  12. Approve subcontracted activities impacting GDP.
  13. Ensure adherence to additional national law requirements for specific products within the regional cluster.
  14. Archive GDP information following records retention procedures.
  15. Support RP/GDP Affiliate quality teams to uphold RP responsibilities.
  16. Assist in revising and administering local SOPs, WI, forms, and templates.
  17. Deal with customer complaints effectively, recording and sharing with manufacturing sites.
  18. Prepare documentation, update trackers, check batch documentation, and communicate internally and externally.

This role requires excellent influencing skills, ability to establish effective working relationships, and excellent verbal and written communication skills.