Experience

Agio Pharmaceuticals Ltd.

• India
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• AGM Corporate Quality Assurance

  • Apr 2019 - Present

  Reporting to Managing director in the organization Leading Quality function at Agio Pharma Limited Heading a team of 18 professionals in the Corporate Quality Assurance Department Conducting review & approval of Quality Management System (QMS) notifications: Change controls through track wise system Deviations & investigation through track wise system Site and Global Corrective & Preventive Actions (CAPA) through track wise system Out of Specification (OOS), Out of Trend (OOT) & Out of Expectations (OOE) Investigation Market /Customer Complaint Investigation Process, cleaning & non-routine validations Review of APQR and Stability Study Data Aseptic Process Validation Media Fill Qualification Independently handling of audits such as TGA, UK MHRA, EU, PICS, MCA Introduction of New Product and provide guidance/suggestions for the development of products. Executing Computer System Validation/Computer Software Assurance as per FDA guideline 21 CFR Part 11, GMAP-5 and GxP assessment. Executing Qualification of Instrument and equipment and PLC Validation. Planning, execution, risk assessment and compliance of internal audit Participating in remediation & certification program on Systems & Processes like Documentation, Training, Preventive Maintenance, Technology Transfer, Complaint, Utilities, Manufacturing Equipment, Self-inspections, Incident Management, Material Control, Production & Process Control, Warehouse & Distribution Control and Supplier Management & Qualification conducted Checking & monitoring the process of commercial & DMF filed products like Drug Dosage (OSD, Parenteral and Topical) and Active Pharmaceuticals Ingredients (APIs) & ensuring its compliance Quality agreement, audit and approval of Public Testing Laboratory and Technical agreements for contract testing laboratories, LL/P2P and third party manufacturers Managing Market Complaints, Field Alert Report (FAR) and Product Recall / Return Procedure Show less



Dr. Reddy's Laboratories

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Manager

  • Nov 2015 - Apr 2019

  • Reported to Head Quality in the organization • Leading a team of 48 professionals and managing the overall QC functions of the department • Managing the Analytical (QC) compliance and administering their troubleshooting activities • Performing comprehensive audits and ensuring compliance; performing QMS Documentation for uninterrupted operations • Directing a complete array of quality control functions across manufacturing facility for regulatory compliance • Assessing release/reject finished products and approving of Out-of-Specification (OOS) investigation reports • Investigating market complaint, deviation, change control, non-conformance, incidence, returned goods, • product recall, and its impact assessments, studying its reports and monitoring implementation of Corrective and Preventive Action (CAPA) • Supervising system audits, transfer of products, validation, change control management, deviation & exception, • requirements of regulated markets • Ensuring that the teams adhere to all the quality standards through precision/calibration & attending sessions Show less



Lupin

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive-Quality Control (QMS)

  • Feb 2012 - Nov 2015



Cipla

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Management Staff

  • Apr 2010 - Feb 2012



Alembic Pharmaceuticals Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Executive

  • May 2005 - Apr 2010