As a Responsible Person your responsibilities will include, though will not be limited to:
· To ensure the management of authorised activities and quality records are maintained accurately.
· CAPA, Deviation, SOP drafting, Training of the team, supplier Audits.
· Co-ordinating with manufacturers and promptly performing any recall operations
· Conducting the suppliers and customer audits as per the procedures
· To ensure that the self-inspections are performed at appropriate regular intervals following a pre-arranged programme and necessary corrective measures are put in place.
· To ensure and approve final disposition of returned, rejected, recalled or falsified products are dealt with effectively.
· Approve any returns to saleable stock, providing quality support and oversight for Distribution Operation review meetings with Distribution contractors.
· Contribute to defining GDP, quality, KPI's and OT review quality indicators with recommendations for actions for improvement in regard to GDP guidelines.
· Ensuring CAPA's are identified, effective temperature control of medicines, temperature mapping.
· Ensuring annual GDP, initial and continuous training programmes are implemented and maintained to all employed staff.
· Ensure Quality Technical Agreements are in place for all outsourced activities and with all sub-contractors.
· Ensure that the Parallel Import design and relabelling is according to the EU GDP standards
· Maintaining required documentations and licenses for the processing of these licenses.
· Extensive experience in the pharmaceutical industry, with a strong background in distribution or quality assurance.
· Thorough understanding of German and EU regulations pertaining to pharmaceutical distribution, including GDP requirements.
· Excellent organizational skills, with a keen attention to detail and accuracy.
· Strong interpersonal and communication abilities, with the capacity to collaborate effectively with internal and external stakeholders.
· Ability to work autonomously, manage multiple priorities, and make informed decisions in a dynamic environment.
As with all Group employees, you'll also be asked to:
· Ensure the work you do is of a high standard and that Group procedures and policies are followed.
· Act as an ambassador for the business, presenting the Group in a positive way with clients, customers, and colleagues.
· Work flexibly and efficiently to meet customer needs, whilst maintaining the highest possible professional standards.
· Always maintain confidentiality and security.
To be successful in this role, you should be able to demonstrate:
· Previous experience as a responsible person.
· Strong, up to date knowledge of Good Distribution Practices
· A supportive nature - and good team-playing mentality
· Being capable of working towards KPIs
· Excellent communication skills
· The ability to work at pace and in a high-pressured environment
Conclusion: The role of the Responsible Person in the pharmaceutical sector in Germany is vital for ensuring the integrity, safety, and quality of medicinal products throughout their distribution journey. By upholding regulatory standards and implementing robust quality management practices, the RP contributes to safeguarding public health and maintaining compliance with applicable regulations.
Job Type: Full-time
Pay: From 100.000,00€ per year
Experience:

• RP: 5 years (Required)

License/Certification:

• PLPI and GDP WDA License (Required)

Work Location: In person