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/Policies and meet 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 current knowledge & compliance with cGMP/GDP regulations is maintained through training and internal audits.
Establish a good working relationship with the Supply Chain Management (SCM) and DRA departments. Coordinate with oversea manufacturing sites for quality aspects such as product defect, testing monograph.
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 are released to the market in accordance with the registered specifications and with local/international regulations. Ensure that an effective Change Control process and Deviation Management are in place.
Audit, supervise and co-ordinate third party activities and ensure that third party manufacture, (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards.
Ensure country organization readiness for all GMP regulatory inspections.
Manage external inspections, Product Complaints, Recalls, Counterfeits and Product tampering according to the Novartis Corporate Quality Manual and local written procedures.
Bachelor Degree in pharmacy or life science-related field.
Min. 5 year experience in pharmaceutical industry in a relevant fields such as Quality Assurance, Quality Control, Regulatory & Registration, Production, or Quality in commercial and marketing.
Has good knowledge in Good Manufacturing Practice (GMP), Good Storage and Distribution Practice (GDP) Fluent in both speaking and writing English.
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