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

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