Senior Chemist - M/s. Balaji Amines Ltd. - Solapur
(2007-04 - 2013-09)
- Handling of GC makes Perkin Elmer
- Handling of wet lab Instruments
- Analysis of Raw material intermediated and finished products
- Handling of dispatch release activity etc.
Executive - Vaasavaa Pharmaceuticals (P) Ltd. - Solapur
(2014-02 - 2023-06)
- Preparation of standard operating procedures and standard testing method
- Preparation of Training Schedule and conducting on job and cGMP training
- Preparation of Validation master plan, preparation of protocol & report for various types of process validation
- Equipment qualification. (URS and PQ protocol & reports preparation)
- Handling of Change control & Deviation control
- Handling of customer complaint, handling of returned goods
- Preparation of Annual Product Review Report
- Handling of internal audits
- Selection, evaluation & Approval of Vendor by site audits
- Selection, evaluation & Approval of Contract laboratory by site audits
- Preparation and Control of Batch Manufacturing Records, issuance & Receipt
- Handling of Batch Release & Dispatch release
- Review of Quality control analytical reports (dispatch docket)
- Preparation of Site Master File and Quality Manual
- Preparation of MFR and DMF (Applicant part)
- Handling of Customer Audits and preparation of compliance report along with CAPA
Senior Executive - Smruthi Organics Ltd. - Solapur
(2023-08 - 2024-01)
- Handling of Documentation related to Engineering/maintenance.(Equipment qualification, preventive maintenance, calibration etc.)
- Handling of internal audits
- Selection, evaluation & Approval of Vendor by site audits
- Handling of Batch Release & Dispatch release
- Review of Quality control analytical reports
- Handling of Customer Audits and preparation of compliance report along with CAPA
- Conducting cGMP trainings
- Preparation and review of Quality trends and APQR reports
Asst. Manager - Radison Labs. Pvt. Ltd. - Humnabad
(2024-02 - 2025-10)
- Handling of customer complaints, return goods
- Preparation of standard operating procedures
- Preparation of Validation master plan, preparation of protocol & report for various types of process validation
- Equipment qualification
- Selection, evaluation & Approval of Vendor by site audits
- Preparation of Site Master File and Quality Manual
- Preparation of BPCR, MPCR and DMF (Applicant part)
- Handling of internal audits
- Selection, evaluation & Approval of contract laboratory by site audits
- Handling of Batch Release & Dispatch release
- Review of Quality control analytical reports
- Handling of Customer Audits and preparation of compliance report along with CAPA
- Conducting on job and cGMP trainings
- Preparation and Review of Quality trends and APQR reports
- Handling of OOS and audit trail
- Handling of product recall
- Handling of change control and deviations
- Preparation of tech transfer report and risk assessment report
QA Manager - Amgis Life Science Ltd. - Vapi
(2025-12 - 2026-02)
- Selection, evaluation & Approval of Vendor by site audits
- Handling of internal audits
- Selection, evaluation & Approval of contract laboratory by site audits
- Handling of Customer Audits and preparation of compliance report along with CAPA
- Preparation of protocol & report for various types of process validation
- Conducting on job and cGMP trainings
- Handling of Batch Release & Dispatch release
- Handling of customer complaints, return goods
- Preparation of Site Master File
- Preparation of BPCR, MPCR and DMF (applicant part)
- Preparation and Review of Quality trends and APQR reports
- Review of Quality control analytical reports
