About the role

1.Responsible for Quality Management system including Change Controls, Deviations, Non Conformances, Incidents and Corrective and Preventive Actions. 2.To acknowledge and handling of Product Complaints and ensuring the investigations and closure. 3.Responsible for disposition and Authorization of change controls, Deviations, artworks, shade Cards, Non Conformances, Yield Non Conformances, Incidents, Annual Product Review and Corrective and Preventive Actions as a designee to head of department. 4.To co-ordinate for handling of Out of Specification (OOS), investigation and closer of OOS. 5.Handling of Out of Trends (OOT), investigation and closer of OOT. 6.Planning and Coordinating the MQR & QQR. 7.Review of issuance, distribution, revision, obsoletion, storage and destruction of documents. 8.Review and approval of documents viz. Specifications/STPs/GTPs/Technical Directions/Protocols/Reports. 9.Review and approval of contract testing laboratory qualification documents. 10.Review and approval of stability protocols and reports. 11.Execution of cGMP training. 12.Training program compliance. 13.To co-ordinate with concerned departments to ensure that GMP documents are updated within defined timeline and align with current Regulatory/GMP requirements. 14.To coordinate and ensure compliance for Audits and Self Inspections. 15.Responsible for Vendor Management. 16.Responsible for Art work/shade card review and approval. 17. To co-ordinate with concerned department’s viz. R&D, RA, QC, MM, Production for review and approval of the required documents (Specifications/STPs/Technical Directions/Protocols/Reports) to in line with current Regulatory/GMP requirements. 19.To perform any other works as and when assigned by Head of department.

Section Manager - Quality Assurance

About the role

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