Address
Form of work
Salary- 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.
