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 : Sr. Manager Quality Assurance
Job Description
Ensure appropriate regulatory compliance for all the products which are scheduled for commercial launch.
• Implement Sandoz/ Novartis Group quality policies; ensure compliance of Local Regulatory/ EU/US/ICH and international guidelines as applicable to Kalwe site.
• Ensure the vendor management for the site according to the SOP.
• Completion of all trainings assigned to individuals role.
• To ensure & coordinate provision of GMP training for the site & authorize GMP documents.
• GMP and abiding and ensuring compliance to the Health, Safety and Environment policy.
• Change control management. Ensure appropriate assessment, coordination, approval and closure of change controls.
• Ensure appropriate timely sign-off of quality agreements and PSAs for all the commercial products.
• Review/Update/Approve control procedures/SOPs specifications/Quality manual/Site master file/GMP documents.
• Responsible to initiate Management Escalation according to the defined procedure.
• To participate and perform vendor audit activity and self-inspections for various departments on the site as per predefined schedules. To participate and perform unannounced inspections for various departments on site.
• Reporting of quality metrics in global cockpit data and quality dashboard.
• Ensure e-compliance at the site.
• Ensure oversight of third party operations.
• Management of External inspections.
Candidate Profile
Masters in Pharmacy, with 12- 15 years experience
Additional Information:
Experience: 12-15 years
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
Job ID: 217072BR
Last Date: 21st August, 2017
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