Sujit Kulkarni
Senior General Manager Global Quality at Aurobindo Pharma
- Role
- General Manager Gqa at Aurobindo Pharma Ltd
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sujit Kulkarni
Working as a Quality professional in a pharmaceutical industry in India for more than 20…
Experience
General Manager Gqa
Apr 2022 — Present · Hyderabad, IN
Job responsibilities:(Dosage Form: Injectable, Tablet, Capsules, Dry syrup, Creams, ointments.) Responsible for Independent Data review team activities for 15 Sites including API and formulations, out which Support for 3 US sites, Aurolife-1,Aurolife-2 and Auro PR Co ordination with all sites on frequent and help them to resolve the iss Implementation and review of Chromatography and non-chromatography data. Identify the training needs of the Group Leaders and the reviewers and provide training. Initiate nonconformance and review and approve for the appropriate CAPA for all the sites. Review and approve the change control as SME and provide comments to sites. Monthly Presenting the data to the Senior management. Review of Method Transfer activity at site. Reviewing the OOS, OOT including manufacturing Investigations data reports of all sites Frequent visits to the sites for compliance Harmonization’s of SOPs across site Participate in all regulatory sites and ensuring no critical observation. Review of stability data required for submission. Implementation of Lean concept across site for o Reduces testing.o Analytical Laboratory Computer validation as per Current CGMP Practices. Updating the Pharmacopeial changes to the Site and R&D. Co-coordinating and Handling of Complaint related to Malta Site. Qualified Auditor for Aurobindo Pharma. Currently in process of adding the API Sites Ensure the identified data integrity issues are handled appropriately.
Education
Kuvempu Vishwavidyanilaya
Master
2008 — 2010
Skills
- Dissolution
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