Job Description
Ensure compliance of the CPO organization with GMP legal and regulatory requirements and the Novartis Quality Manual and Policies.
Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
Ensure that a local Quality System and Standard Operating Procedures are in place for all GMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
Report monthly Key Quality Indicators (KQIs) related to GMP/GDP activities to CPO QA and monitor them and assure that gaps are addressed appropriately in order to mitigate risk.
Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
Establish a good working relationship with the Supply Chain Management (SCM) and DRA departments.
Ensure that co-ordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
Ensure that all drug products and Investigational Medicinal Products (IMP) are released to the market in accordance with the registered specifications and with local/international regulations.
Ensure that an effective Change Control process is in place.
Ensure quality oversight of third party and coordinate all required activities to guarantee that third party manufacture, (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards.
Establish good working relation with External Supply Organization (ESO) allowing to keep QA oversight on all partners (e.g. third party activities).
Ensure CPO readiness for all GMP/GDP regulatory inspections.
Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures. Support / participate in NEM cases as required and ensure relevant CAPAs have been completed/closed.
Together with Local Leadership Team members, ensure conduct of adequate training at the CPO for all GMP and GDP related activities by defining, planning and supporting training activities.
Minimum Requirements
Minimum 5 years experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production, distribution or a directly related area. .
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