Regulatory Expert in Pharmacy/Medicines/Healthcare

Posted 27 March by Reed Talent Solutions
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Salary not specified
Baden-Württemberg , Germany
Permanent, full-time
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Posted by Reed Talent Solutions
  • Location: Baden-Baden, Germany
  • Job Type: Full-time
  • Salary: Competitive, based on experience
  • Years of Experience: 5 to 7 years
  • Qualification: M.Pharm in Pharmaceutical Science or Medicine


We are seeking a highly qualified Responsible Person with extensive experience in the pharmaceutical industry. The successful candidate will have a strong background in distribution or quality assurance and a thorough understanding of German and EU regulations pertaining to pharmaceutical distribution, including Good Distribution Practice (GDP) requirements.

Day to day of the role
  • Manage authorised activities and maintain accurate quality records.
  • Handle CAPA, deviations, SOP drafting, team training, and supplier audits.
  • Coordinate with manufacturers and perform recall operations promptly.
  • Conduct supplier and customer audits in accordance with procedures.
  • Ensure regular self-inspections and implement necessary corrective measures.
  • Approve final disposition of returned, rejected, recalled, or falsified products.
  • Provide quality support for Distribution Operation review meetings.
  • Define GDP quality KPIs and review quality indicators, recommending actions for improvement.
  • Ensure effective temperature control of medicines and conduct temperature mapping.
  • Implement and maintain annual GDP training programmes for all staff.
  • Maintain Quality Technical Agreements for all outsourced activities and subcontractors.
  • Ensure compliance with EU GDP standards for Parallel Import design and relabelling.
  • Maintain documentation and licenses for processing.


Requirements
  • M.Pharm in Pharmaceutical Science or Medicine.
  • Minimum 5 years of experience in a similar role within the pharmaceutical industry.
  • Knowledge of PLPI license, GDP Licences, EU-QPPV, RP.
  • Strong knowledge of Good Distribution Practices.
  • Excellent organisational skills with attention to detail and accuracy.
  • Strong interpersonal and communication skills.
  • Ability to work independently and manage multiple priorities in a dynamic environment.

Reference: 52385973

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