Samadhan Mali
Daman
Summary
Dynamic Quality Assurance Officer with extensive experience at Macleods Pharmaceutical Limited, adept in eBMR and eBPR systems. Proven track record in executing process validations and ensuring compliance with GMP standards. Skilled in Minitab and effective communication, driving quality improvements and operational excellence in manufacturing processes.
Overview
6
6
years of professional experience
Work History
Senior QA officer
Macleods Pharmaceutical Limited
Daman
03.2024 - Current
- Executed line clearance activities in manufacturing and packing areas.
- Ensured proper sampling of intermediate and finished products.
- Conducted in-process checks during manufacturing and packing stages.
- Monitored manufacturing processes in compliance with SOP and GMP standards.
- Participated in execution of process and cleaning validations.
- Reviewed filled BMR and BPR online for accuracy.
- Performed periodic batch audit trail reviews and batch process report evaluations.
- Calibrated IPQC apparatus, including balance DT, friability tester, hardness tester, and moisture analyzer.
Quality Assurance Officer
Alkem Laboratories Limited
Daman
01.2021 - 03.2024
- Handling of eBMR,eBPR & eLogbook.
- Perform the Line Clearance Activities in Manufacturing and Packing area.
- Ensure proper sampling of intermediate or finished product.
- To Perform in process checks during Manufacturing and Packing Stage.
- To involve in execution of Process Validation and Cleaning Validation.
- Online review of filled BMR & BPR.
- To Perform the Batch Audit Trail, Periodic Audit Trail review and Batch Process Report review.
- To monitor the manufacturing process according to SOP as well as GMP.
- To Calibrate IPQC Apparatus like Balance, DT Apparatus, Friability, Hardness Tester (Erweka) and Moisture Analyzer.
- Sampling rod/ Dies management & its record.
- All IPQA activities conducted on the shop floor.
Education
M. Pharmacy - Pharmaceutics
Sandip Institute of Pharmaceutical Science.
Nashik11-2020
B. Pharmacy - Pharmaceutical Sciences
SMBT Collage of Pharmacy
Nashik06-2018
HSC - Science
Rashtriya Junior Collage
Chalisgaon05-2014
SSC - Ssc
TSMV
Chalisgaon06-2012
Skills
- HITPHAMS (eBMR, eBPR, eLogbook)
- eDMS (Documentation Management system)
- LIMS (Laboratory Information Management System)
- Nichelon eTMS (Training Management System)
- Minitab
- Trackwise
- Macportal
- PLMS
- ERP
- Microsoft Office
Personal Information
- Date of Birth: 24/02/1996
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that the information provided above is true and accurate to the best of my knowledge and beliefs.
Languages
- English
- Hindi
- Marathi
Roles And Responsibilities
- To Perform the Line Clearance Activities in Manufacturing and Packing area.
- Ensure proper sampling of intermediate or finished product.
- To Perform in process checks during Manufacturing and Packing Stage.
- To involve in execution of Process Validation and Cleaning Validation.
- Online review of filled BMR & BPR.
- To Perform the Batch Audit Trail, Periodic Audit Trail review and Batch Process Report review.
- To monitor the manufacturing process according to SOP as well as GMP.
- To Calibrate IPQC Apparatus like Balance, DT Apparatus, Friability, Hardness Tester (Erweka) and Moisture Analyzer.
- Sampling rod/ Dies management & its record.
- Preserved sample Destruction.
- All IPQA activities conducted on the shop floor.
Timeline
Senior QA officer
Macleods Pharmaceutical Limited
03.2024 - Current
Quality Assurance Officer
Alkem Laboratories Limited
01.2021 - 03.2024
M. Pharmacy - Pharmaceutics
Sandip Institute of Pharmaceutical Science.
B. Pharmacy - Pharmaceutical Sciences
SMBT Collage of Pharmacy
HSC - Science
Rashtriya Junior Collage
SSC - Ssc
TSMV