Salary:
Competitive.
Job Timings:
8 AM to 5 PM.
Requirements:
Graduation in pharmacy background or any relevant degree.
About The Role:
- Supervision and motivation of national approval team members.
- Contact person for all team members.
- Proactively ensuring smooth team operations and effective collaboration.
Responsibilities:
- Creating an inspiring team environment with an open communication culture.
- To ensure the management of authorized 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 prearranged 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 subcontractors.
- 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.
Candidate Requirements:
- Minimum 5 years of relevant experience.
- an analytical and problem-solving mindset.
- excellent organization and time management skills.
- commercial or pharmaceutical training.
- good knowledge of English.
- confident use of MS Office.
- ability to work in a team.
- flexibility and commitment; forward-thinking.
Benefits:
- Competitive salary and performance-based incentives.
- Comprehensive benefits package including health insurance.
- Opportunities for career growth and advancement within a global organization.
- Dynamic and collaborative work environment with a diverse and inclusive culture.
Job Category: Regulatory Affairs Manager
Job Type: Full Time
Job Location: United Kingdom