Ajay Patidar
Deputy Manager-Quality Assurance | Ajanta Pharma, Pithampur. Driving core QA functions includes QMS, IPQA, Technology Transfer, Validation, Audit & Compliance, Vendor Qualification, IT QA.
- Role
- Deputy Manager Quality Assurance at Ajanta Pharma Ltd
- Location
- Indore, MP, IN
- LinkedIn followers
- 500 followers
About Ajay Patidar
Pharmacy Graduated Quality Assurance Professional with 15 of considerable experience in…
Experience
Deputy Manager Quality Assurance
Dec 2019 — Present · Indore, IN
Responsible for the Quality Management System (QMS) establishment, maintenance & implementation to provide consistency in managing activities performed at sites to meet customer expectations, applicable regulatory requirements, and Ajanta policies and standards. To lead the inprocess quality assurance activities for monitoring / maintaining the quality & GMP compliance in manufacturing & packing area. Worked in green filed project at Ajanta Pharma Pithampur and participate in establishment of site for manufacturing of OSD product. Investigation of market complaints, deviations, out of specification (OOS) results, out of trend (OOT) results, incidents, non-conformance (NCR), return goods etc. Review and assessment of audit trail observation and investigation / assessment reports. Review and approval of Annual Product Quality Review (APQR) report. Review, approval, effectiveness monitoring and closure of change control proposals. To perform the self inspection, review of compliance report and closure of audit reports. To coordinate in Quality Risk Management activities. Review, approval, closure and effectiveness monitoring of corrective & preventive action (CAPA). To release / rejection of finished goods and semi finished goods. To participate in manufacturing process technology transfer, review of transfer protocol and reports. Review and approval of process performance qualification protocol & reports. Review and approval of hold time study protocol & reports. To ensure the audit readiness and its compliance at site. Review of vendor complaint investigation. Review and approval of standard operating procedure and batch record. Review and approval of monthly reports, QMS trends etc. To coordinate in quality review meetings. Global Impact Assessment of Pithampur site.
Education
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor of Pharmacy - BPharm, Pharmacy
Rajeev Gandhi Prodyogiki Vishwavidhyalaya Bhopal
Bachelor of Pharmacy, Pharmacy
2005 — 2009
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