Job Summary: The QA Specialist will implement and maintain the local Quality System in the areas of GMP, GCP and GPvP, in accordance with the Novartis Quality Manual, the local Quality Plan, and the local regulatory requirements. In cooperation with local DRAs, keep abreast of regulatory requirements, and update local management and QA Head on the possible ramifications of regulatory changes and their impact on the quality, medical, clinical (if any) PV and supply processes.
Key Duties and Responsibilities:
Ensure oversight of POP (Patient Oriented Programs) activities in the cluster (if applicable).
Ensure that a Product Specific Annex is in place to enable the sites release the drug products in accordance with the registered specifications and in accordance with local/international regulations and ensure that a respective Change Control procedure is in place.
Work closely with the tender team and ensure that the global tender procedure is followed and implemented locally and tender annex is in place to enable the release of products without local Marketing Authorizations to the country in compliance with the quoted specifications.
Ensure conduct of adequate training and refreshers for all associates in the cluster for GMP, GCP and GPvP activities by defining, planning and supporting training activities.
Support Clinical Operations (if any), Medical Affairs and Pharmacovigilance associates with quality related issues and provide guidance when necessary.
Oversight, supervise and coordinate 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 that deviations and incidents are properly managed in Track Wise and that escalation is performed when required.
Participate/Conduct QA selfinspections and ensure implementation of corrective actions resulting from the inspection outcome.
Support the cluster readiness for GCP (if applicable) and GPvP regulatory inspections.
Manage external inspections, complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures. Support / participate in NEM cases as required.
Qualifications, Skills and Experience:
The applicant must hold a university degree in life science or related field
At least four years of related work experience
2 5 years’ experience in the pharmaceutical industry (quality assurance, quality control or production) or a directly related field
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market cap and sales. Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec/Glivec), ciclosporin (Neoral/Sandimmun), letrozole (Femara), methylphenidate (Ritalin), terbinafine (Lamisil), and others.