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Novartis Pharma Produktions GmbH is the German site of the international network of Novartis Pharma Production. The site is located in the beautiful Black Forest with direct connections to Basel (Switzerland). Here are producing around 560 people in semi-solid and solid pharmaceutical for the world market.
For our site we are searching a Compliance Head (m/f) who leads the site’s Compliance organization, which is responsible for the overall compliance of the site’s systems of handling, manufacturing and distribution of Pharmaceutical products.
• Ensure that all aspects of the handling, manufacturing and distribution of Pharmaceutical products at the site comply with the requirements of the Novartis corporate quality manual and policies and meet all relevant cGMP regulatory and legislative requirements
• Ensure that local quality system and standard operating procedures are in place and that compliance with cGMP is maintained through training and audit
• Manage the implementation of Novartis Policies (Novartis Quality Manual) to ensure quality processes are maintained and current
• Manage critical complaints, recalls, counterfeits and product tampering according to the Novartis corporate quality manual and support / participate in NEM cases as required
• Manage supplier qualification and ensure its proper status
• Manage qualification of equipment and utilities and ensure its compliance
• Manage PQR management, ensure all PQRs are prepared on time in line with GMP legislation
• Manage launches and transfers, ensure quality oversight for its successful conclusion
• Manage quality agreements, ensure all QA agreements needed are in place
• Manage and ensure regular quality presence on the shoopflor
• Manage implementation of Data integrity plan and Quality plan
• Manage quarterly Quality reviews
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the whole site
• Ensure that coordinated contact is maintained with the regulatory authorities and the local partners (suppliers, 3rd parties, licensees, distributors)
• Audit, supervise and coordinate 3rd party activities and ensure that Pharmaceutical manufacturing, (re-) packaging, (re-) labeling, storage and/or distribution of Novartis products is in compliance with Novartis standards
• Manage quality agreements for contractors and contractees, including contract laboratories
• Ensure consistency of quality related processes and procedures across the Plant
• Work with the Plant teams to improve quality management
• Review and approve all relevant regulatory documents being sent to external bodies
• Ensure readiness for and plan, manage and leas Health Authority inspections
• Act as role model in accordance with the Novartis Values and Behaviours and the Leadership standards
• Ensure health & safety procedueres are followed i.e. near miss accidents, workstation assessment etc.
• Responsible for managing the team
• Responsible for the budget in close cooperation with the QA Head
• Manage and report Quality KPIs
Compliance Head (m/f)