Sr. Team Leader (CQA) - Strides Pharma Science Ltd.
(2024-02)
Corporate Quality Assurance / Supplier Quality Management / Audits
- Planned, prepared, and executed annual audit schedules, coordinating customer, regulatory, internal, and supplier audits in compliance with cGMP, GLP, and organizational quality standards.
- Led internal and external audits to ensure adherence to company policies, regulatory guidelines, and industry-specific requirements.
- Handled customer and regulatory audit responses, ensuring timely closure of observations and maintaining a state of inspection readiness.
- Managed supplier quality programs with a team of 10 reportees, overseeing vendor qualification, performance monitoring, and compliance with contractual and regulatory expectations.
- Qualified and audited Contract Manufacturing Organizations (CMOs), External Service Providers (ESPs), and Contract Testing Laboratories (CTLs) to verify compliance with defined quality criteria.
- Facilitated and conducted on-site vendor audits, assessing facilities, documentation systems, and operational practices for regulatory alignment.
- Managed vendor complaints, change controls, and CAPA (Corrective and Preventive Actions) processes to ensure timely and effective resolution.
- Reviewed and maintained third-party audit reports, ensuring complete, traceable, and compliant records for regulatory readiness.
- Collaborated cross-functionally to implement continuous improvement initiatives in supplier quality management systems.
Asst. Manager in Analytical Q.A - Ind-Swift Ltd.
(2022-05 - 2024-02)
- Performing an extensive review of documents such as SOPs, specifications, testing methods, protocols and reports.
- Analysing analytical data related to raw materials, packaging materials, finished and semi finished product along with in-process and stability samples co-ordinating the release / reject process for the same in SAP.
- Responsible to resolve the problems during routine analysis.
- Managing review of analyst qualification certification in the laboratory.
- Spearheading the investigation and closure of OOS, deviations, change control, incidents and laboratory investigations as well as OOT and extereaneous peak through trackwise system identification of root cause and CAPA.
- Conducting trainings on SOPs along with awareness sessions with respect to incidents,OOS and deviation.
- Examining calibration, qualification documents of all Q.C instruments, reviewing the annual calibration and preventive maintenance schedule.
- Inspection and qualification of third party testing laboratories.
- Leading monthly audit trail review of Empower-3 using HPLC, GC,UV,IR and KF among others.
- Steering lab rounds and upkeep as per GMP compliance.
- Accountable for the explanation of analytical data in front of Auditor.
Sr.Executive in Analytical Q.A - Jubilant Generics Ltd.
(2012-10 - 2022-05)
- Reviewed documents such as SOPs, specifications, testing methods, protocol and reports.
- Assisted in troubleshooting during sample analysis at QC lab.
- Reviewed analytical raw data of batches sent for testing at outside approved laboratory, warranted testing procedure as per standard testing procedure.
- Worked with the consultants for the release / reject of finished products for US Market.
- Steered lab rounds and upkeeps as per compliance.
- Reviewed analytical raw data related to raw materials, packaging materials, finished and semi finished products along with In-process and stability samples coordinate the release/ reject process for the same in SAP.
- Coordinates electronic data sign off 2 (HPLC, GC, UV, IR,and KF, pH metre.
- Responsible for creation, activation and deactivation of users login and preparation of Instrument methods and method set in EMPOWER 3.
- Active participant in closure of OOS , deviations, change control, incidents and laboratory investigations as well as OOT and extraneous peak through trackwise system.
Technical Supervisor - Cadila Pharmaceutical Ltd.
(2012-04 - 2012-10)
- Responsible for the analysis of In-process, Finished products, and stability samples.
- Accountable to Prepare COA for release.
- Analysis of Stability samples.
- Preparation of specifications and STP.
Sr. Officer in Q.C - Akums Drugs and Pharmaceutical Ltd.
(2010-11 - 2012-04)
- Analysis of IP-FP samples.
- Preparation of Analytical reports of Finished product and stability samples.
- Responsible for providing the analysis results of IP-FP samples to QA.
- Responsible for the daily calibration of instruments in Lab.
Assistant Professor - Om bio science institute of pharmacy
(2010-04 - 2010-11)
Work as an Assistant Professor for B.Pharma and M.Pharma
