Manager Quality Assurance Post Vacant for Pharma Candidates @ Novartis

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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

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