Avadhesh Patidar
Senior General Manager - Quality @Kopran Ltd
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WORK HISTORY
Senior General Manager - Quality @Kopran Ltd
Mumbai, IN
Overall responsible for Site Quality function1. Strategic direction on cGMP quality system and leading 2 formulation site teams for regulatory inspections. Heading the Quality function for two formulation plants of a $60M+ pharmaceutical company, overseeing a team of 100+ professionals in QA, QC, IT and validation.3. To monitor site quality goals in alignment with organizational goals.4. To manage and escalate quality/compliance issues to executive leadership.5. To monitor effectiveness of the Quality Management System & holding periodic Management Reviews.6. Partner with R&D, manufacturing, and supply chain teams to resolve quality-related issues, significantly improving product yield, and accelerating time to market.7. To monitor QA & QC teams on critical quality issues for ensuring timely & accurate product release.8. To conduct Quality audits of Injectable facilities (CMO) to confirm compliance with USFDA and EU-GMP.9. To ensure that production processes are validated at appropriate ranges & seamless technology transfer of products from R&D/ other sites to manufacturing plant.10. To review and Approve BMR & BPR of OSD and Oral suspension products.11. Approval of changes including changes to process, equipment, procedures, and computerized systems.12. To ensure timely and thorough investigations of Deviations, Incident, Market compliant, out of specification results with implementation of holistic CAPAs. To manage supplier quality function for products/services impacting the site.14. Approval of Process Validation, Cleaning Validation, Equipment Qualification (IQ, OQ and PQ) protocol and reports.15. To Set annual budget and managing resources in order to meet annual budget.16. To Provide support on GMP advice related to design, qualification & timely validation of products/ projects.17. To Recruit and develop staff, conduct performance reviews, establish development plans and manage resources.
EDUCATION
Barkatullah Vishwavidyalaya
M.Sc., Microbiology
Barkatullah University, Bhopal
B.Sc, Microbiology
SKILLS
ABOUT AVADHESH PATIDAR
Professional Summary: An Expert who has in-depth knowledge of QC, QA, Production…
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