A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Manager Country Quality Assurance
Job Description
Major Accountabilities
• 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
• 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
Candidate Profile
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
Additional Information:
Experience: 8-12 years
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Quality
Job ID: 230582BR
Last Date: 21st January, 2018
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