Officer In Quality Control Department - Ajanta Pharma Limited
(2025-05)
- Handling of various the Quality Control instruments
- Handling of various electronic systems Lims,e-log, EWS
Executive in Quality Control Department - Zentiva
(2024-11-15 - 2025-02-28)
- Handling of HPLC and other physical testings
Confirmed as employee in QC(Exhibit Department) - TORRENT PHARMACEUTICALS LIMITED
(2022-12-12 - 2024-11-07)
- Handling of HPLC and other physical testings
- Reporting and processing various of analytical test data
- Performed all the Test such as ASSAY,RELATED SUBSTANCES,CONTENT UNIFORMITY,DISSOLUTION,BLEND UNIFORMITY,CLEANING VALIDATION
Apprentice in QA(FORMULATION)department under DATA RELIABILITY CELL - TORRENT PHARMACEUTICAL LIMITED
(2021-12-06 - 2022-12-05)
Worked as a trainee for 1 month in J.B.CHEMICALS AND PHARMACEUTICALS. Has knowledge of Data integrity And ALCOA++. 21CFR,GMP Guidelines,ICH Guidelines,CAPA,OOS,OOT,Deviation,Incident,Change Control, Calibration,GMP,CGMP.
- Verification of Audit trail available Quality control instruments in order to ensure data integrity in the analytical records
- HPLC (EMPOWER)
- GC (OPEN LAB)
- LCMS (ANALYST)
- KARL FISCHER(TIAMO)
- UV/IR (LAB SOLUTION)
- Hardness Tester (Erweka MC.Net)
- DISSOLUTION(DISSOLUTION WORKSTATION)
- Approving privilege matrixes and their testing for Data reliability in order to compliance with 21 CFR part 11 and EU Annexure XI
- Performed System Audit trial in Qc instrument Software With the help of IT Admin to ensure login date and time stamp, login/Passwords Policies, System /Securities policies, Audit trail Policies and Privileges accesses control, deleted records, Data backup (hot/cold/Daily backup)
- Participated in Internal Audits for Quality compliance
- Monitoring QC Lab online activity in order to compliance with cGmp, Data integrity, GDP and SOP standards
- Random review of on going and released reports of all sections of QC to ensure Compliance as per (GDP, SOP,ALCOA++) adequacy of laboratory investigations,OOS,OOT,Deviations,Lab incident, CAPA etc
- To plan scheduled audit trail review for both CDS and Non CDS Softwares
- Faced USFDA AUDIT,Turkey audit, Malta audit
