Name of Post: Manager Country Quality Assurance
Major Accountabilities
Country quality oversight for
Technology transfer projects at Contract anufacturing 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
§ Number of successful Technology transfer and subsequent commercial manufacturing. § Number of raw material supplier managed § Number of batch releases § Number of QM and GOP implementations § Number of Quality Incidences § Number of Artworks § Number of warehouses managed
Minimum requirements
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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