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  • Posted: Apr 27, 2017
    Deadline: Not specified
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    For more than 130 years, Boehringer Ingelheim has been committed to the research, development, and manufacturing of new medications with high therapeutic value for people and animals. As a family-owned pharmaceutical company, Boehringer Ingelheim is able to take a long-term view and invest heavily in research and development. We are proud of addressing some ...
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    Quality & Compliance Officer

    Job description

    • Quality Management System Oversight
    • GDP responsible towards the authorities
    • Local Pharmaceutical Complaint Officer (LPCO)
    • Responsible Pharmacist and Product supply support
    • Management of External Service Providers

    Duties & Responsibilities

    • Establish, maintain and improve the Quality Management System in South Africa and Lead the Quality Management Reviews (QMR) in South Africa
    • Responsible Pharmacist performing Batch Market Release as per the local Health Authorities Regulations. And decide on the final disposition of returned, rejected, recalled or falsified products
    • Coordinate and promptly perform any recall operations for medicinal products and owner of the LAC (Local Advisory Committee) ensuring proper escalation of major and critical Product/Quality Defects
    • Ensure that relevant customer complaints are handled effectively on timely manner
    • Handle deviations, investigations and CAPAs. Ensure adequate CAPA plans are tracked for completion.
    • Ensure that initial and continuous training programs are implemented and maintained.
    • Manage audits by Corporate or inspections by local Authorities in respect to GMP/GDP.
    • Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
    • Manage external GxP service providers in all quality relevant aspects during the life cycle of a contract. This might include the following GxP service providers:
      • Re-packagers – secondary packaging distributors
      • freight forwarders
      • warehouses
      • graphic offices
      • contract laboratories
      • Co-promotion / Co-Marketing partners
      • Out-licensing partners
      • Outsourced services with GMP/GDP relevance

    Requirements

    • Must be a Pharmacist, licensed by the Local Health Authorities and registered as the Responsible Pharmacist.
    • Degree in Pharmacy
    • Solid experience in quality management with minimum 4 years of leadership experience
    • Strong knowledge of international regulations/guidelines concerning GDP/GMP and Quality Assurance
    • Very good communication and inter cultural skills
    • Interdisciplinary thinking and open communication
    • Excellent interpersonal skills, assertiveness, decision-making ability

    Method of Application

    Interested and qualified? Go to Boehringer Ingelheim on tas-boehringer.taleo.net to apply

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