Experience

Megafine Pharma P Limited Nashik

• India
• Biotechnology Research
• 1 - 100 Employee

• Junior Manager Quality Assurance

  • Dec 2021 - Present

  • Receipt, registration, communication, investigation & handling of Market / Customer Complaints, deriving appropriate CAPA based on root cause analysis, as per approved procedure and regulatory requirements. • Review, tracking and investigation of Unplanned Deviations, Out of specifications, Out of trends and related CAPA monitoring. • Tracking, review, closure and effectiveness check of Corrective and preventive actions (CAPAs) and Global action / CAPA. • Initiating, conducting and managing cross functional investigations in coordination with respective departments. Participates and review of Cross functional investigation related to batch failures / OOT, deriving appropriate CAPA based on root cause analysis, as per approved procedure and regulatory requirements. • Initiation, review, evaluation, tracking and closure of change control proposals as per procedure. • Review of Risk assessments reports , deriving mitigation plans, Review of FMEA reports. • Responsible for preparation and review of Trend report for Complaints and unplanned deviations. To assess / identify repetitive incident and to check adequacy of derived CAPAs. • Preparation of Audit response reports, follow ups and closure of committed actions. • Proficiency in the use of common and specialized software (TrackWise) during handling of QMS activities i.e. Change controls, Complaints, Deviations, CAPA, etc. • Equipment Qualification and scheduled requalification activity. Review of qualification protocol and reports. • Review of master batch manufacturing records and equipment cleaning records. • Review and approval of executed batch manufacturing records and equipment cleaning records. • Preparation and compilation of Annual product quality review (APQR/ APR) as per scheduled timelines. • Responsible for walk a round in cross functional department to ensure Good manufacturing practices. • Actively participates in preparation of Regulatory audits in setting up back up room, runners, scribers etc. Show less



SUN PHARMA

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Executive

  • Jun 2017 - Dec 2021

  • Handling and Monitoring of Change controls, and closure of change controls. • Handling of Event / Incidents, Failure investigations and related CAPA monitoring. • Handling and Preparation of Audit Response reports and related CAPA monitoring. • Equipment Qualification and scheduled requalification activity. • To help in compilation of DMF documents. • Preparation of Organization chart and job responsibilities. • Carrying out Online audit to ensure cGMP compliance in store, manufacturing plants, BSR. • Review of Master Batch manufacturing records as per technology transfer pack. • Review of Executed Batch manufacturing records and Equipment cleaning records. • Issuance and retrieval of documents like BMR, ECR , BPR Preparation of Site Master File Show less



Ipca Laboratories Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Quality Assurance Officer

  • Jul 2015 - Apr 2017



SUN PHARMA

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Officer

  • May 2012 - Feb 2015



Emcure Pharmaceuticals Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Officer

  • Mar 2010 - May 2012