Novartis
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.
Job Title: Manager Country Quality Assurance
Job Description:
Country quality oversight for Technology transfer projects at Contract manufacturing site inline with local regulatory guidelines & Novartis quality manual. New material vendor identification and qualification as per applicable procedures. Batch release activities as per applicable procedures in SAP. Quality agreement preparation and negotiations with Contractor. Quality Management System Implementation within department. Novartis Quality Module (QM) and Global Operating Procedure (GOP) implementation as per Global Timelines. Quality Incident management (Change Control, Deviation, Complaint, Quality Event etc) in Trackwise System. Implementation and track of Quality Plan. To conduct training and management of training system. Preparation and maintenance of local SOP’s. Artwork management Supply chain Quality oversight Health Authority communication and coordination Coordination with local and applicable health Authority for responding queries, Audits and CAPA plans. Quality oversight of the product dossiers and to support documents review management to maintain in current state.
Key Performance Indicator
Qualifications: B. Pharm / M. Pharmacy or
Equivalent English and Local language – 8-12 years of relevant industry experience in Site Quality Assurance, Contract Manufacturing QA. – Proactive leader for ascertaining completion of activities – Project Management skills
