Keshav Nikam
\"Experienced Pharmaceutical Quality Leader | Sr. Manager of Quality Assurance | 17+ Years in Operations QA and Compliance Management\"
- Role
- Sr Manager at Apotex India
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Keshav Nikam
I am a seasoned pharmaceutical professional with over 16 years of experience specializing…
Experience
Sr Manager
Apr 2022 — Present · IN
Sr. Manager - Quality Assurance at Apotex Research Pvt. Ltd. As the Manager of Quality Assurance at Apotex Research Pvt. Ltd, I am proud to contribute to the success of a leading global pharmaceutical company dedicated to delivering high-quality, affordable medications to patients worldwide. Role Highlights: Team Leadership: Leading a team of 20 dedicated professionals in Operations Quality Assurance, ensuring our oral solid dosage formulations meet the highest quality standards. Quality Management: Overseeing Quality Management Systems, including Change Control, Deviation handling, and Root Cause Analysis. Audit Expertise: Managing various audits at our site and crafting responses to observations, ensuring compliance with global procedures and Good Manufacturing Practices. Regulatory Support: Coordinating with cross-functional teams to provide essential support for ANDA submissions to Regulatory Affairs and preparing technical justifications for Regulatory queries. Document Expertise: Proficient in the preparation and review of SOPs, work instructions, technology transfer documents, Master BMR & BPR. Audit Readiness: Ensuring the shop floor is audit-ready at all times and successfully managing regulatory, customer, and internal audits. Process Optimization: Leading initiatives to streamline systems, enhance operational effectiveness, and meet operational goals within cost, time, and quality parameters.🤝 Interpersonal Skills: Possessing strong planning, time management, and interpersonal skills to drive collaboration and success.Connect with me to learn more about our exciting work at Apotex Research Pvt. Ltd. and explore potential collaborations. Let\'s make a positive impact on healthcare together!#PharmaceuticalIndustry #QualityAssurance #ComplianceManagement #RegulatoryAudits #OperationsQuality
Education
North Maharashtra University
B.Pharm, Pharmaceutical Sciences
Girna Public school
North Maharashtra University, science
1991 — 1996
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