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Process Quality Manager QM - Oferta z Jobs.pl

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Process Quality Manager QM

Nr ref.: /JOBS.pl

  • Reference Number: 895097-W

    Type of placement: Permanent

    Location: Berlin, Germany


    Identify process improvement opportunities and champion their implementation, as assigned
    Work independently and provide expert advice to groups within the organization
    Provide mentoring, leadership, direction and training to new and existing (Senior) Quality Specialists
    Participate in SOP and process development as assigned
    Develop training materials and/or deliver training related to processes and/or systems, as assigned.
    Provide audit and inspection support as assigned. This may include: providing assistance/advice for audit/inspection preparation; representing Quality Management in audits and inspections as required; reviewing assigned audit/inspection responses
    Request audits of investigational sites, local offices or processes as needed
    Provide support for management of quality issues. Facilitate and advise on corrections and corrective actions related to designated quality issues. Develop preventive actions and ensure resolution by Operational or Line Management staff, or Quality Management. Facilitate local compliance to the corrective and preventive action (CAPA) program
    Oversee all Quality Control activities in local depot / warehouse
    Instruct and train QC staff and other depot staff as needed
    Perform QC release of Medicinal Product batches and batches of other quality critical Clinical Trial Materials (CTM)


    Relevant pharmaceutical industry, CRO, Clinical or Medical experience required
    Experience in a GxP regulated, global environment with focus on GMP required
    Leadership/project management/technology/business operations experience preferred
    Training experience, as appropriate, required
    Relevant experience in Quality Management preferred
    Experience with primary and secondary manufacturing
    Excellent English language written and verbal communication skills
    Fluent in both written and spoken German


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