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
RESPONSIBLE FOR
* Assisting QA for efficient functioning through monitoring and good documentation.
* Implement Sandoz / Novartis Group quality policies; ensure compliance of Local Regulatory/ EU/US/ICH and international guidelines as applicable to Kalwe site.
* Ensure appropriate closure of market complaints investigations in a timely manner.
* Ensure appropriate Handling of Deviations investigations & Timely closure.
* Ensure appropriate OOS/OOE investigations & their timely closure.
* GMP and abiding and ensuring compliance to the Health, Safety and Environment policy
* To ensure & coordinate provision of GMP training for the site & authorize GMP documents.
* Ensure that release/rejection of starting materials, packaging materials, purified water, semi-finished and finished products.
MAIN RESPONSIBILITIES
* Ensure that release/reject of starting materials, packaging materials, purified water, semi-finished and finished products in a timely manner and according to set priorities and set standards. Ensure review of records-Batch and analytical documents.
* Ensure appropriate, timely investigations to close market complaints.
* Ensure availability of periodic review reports & trends (as applicable) for market complaints, OOS/ OOE, Deviations & CAPAs.
* Ensure all CAPAs identified as a result of OOS /OOE investigations/deviations/market complaints investigations/ any other quality events / etc. are tracked for timely implementation.
* Maintain confidentiality; ensure safe custody and efficient handling of company documents and materials.
* Represent site in Customer/Authority inspections. Responsible for compliance to regulatory inspections and communications related to that.
* Responsible to initiate Management Escalation according to the defined procedure.
* As a part of business continuity process, is responsible supporting business-specific changes on content/functionality.
* Ensure appropriate timely investigation to close deviations investigations.
* Ensure & approve yearly (timely) product review (APR/PQR) as per regulatory requirement.
* User management in stand-alone systems and Creation, modification, activation and deactivation of user profiles in the all system in QC department.
* Ensure OOS procedures are followed as appropriate. Approve /authorise OOS investigation forms.
* Ensure stability programme for commercial products as per regulatory requirements, review and approve stability protocols, reports and investigations.
* Maintain confidentiality; ensure safe custody and efficient handling of company documents and materials.
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Experience: 12 - 15 years of experience in handling quality assurance for formlulations unit.
Additional Information:
Experience: 12-15 years
Location: Navi Mumbai
Education: M.Pharm, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 142380BR
End Date: 31st May, 2014
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