Ashutosh Tiwari
Mohali
Summary
Quality Assurance specialist with over 10 years of experience in the pharmaceutical industry, focusing on CAPA, deviation handling, change control, and batch record reviews. Expertise in SAP, EDMS, and Trackwise enhances operational efficiency. Strong problem-solving skills and meticulous attention to detail ensure adherence to quality standards. Committed to contributing to team success through collaborative efforts and proven capabilities.
Overview
11
11
years of professional experience
Work History
Sr. Executive- QA
Sun Pharma
Mohali
04.2021 - Current
- Managed deviations and investigations on shop floor, assessing impacts on product quality and ensuring timely closure through CAPA tracking.
- Initiated and reviewed change controls in collaboration with CFTs, including sample and process investigations.
- Oversaw retention sample management and conducted visual inspections of control samples.
- Executed all SAP activities relevant to job responsibilities.
- Prepared responses for internal audits and ODR observations, ensuring compliance with guidelines.
- Issued and approved batch production records via batch printing and record management systems.
- Initiated CAPEX requests, purchase requisitions, and managed purchase orders for QA department.
- Reviewed and released executed batch manufacturing records for regulatory filings and commercial batches.
Team Member - QA
Dr. Reddy's Laboratories Ltd. FT06
Baddi, Himanchal
01.2019 - 03.2021
- Effectively managed equipment clearance, addressing delays to ensure project timelines.
- Led successful audits in Ukraine and Russia, verifying adherence to regulatory standards.
- Assured compliance through rigorous in-process checks and effective management of non-compliance instances.
- Oversaw implementation of SOPs, tracked CAPA, and ensured compliance on shop floor.
Officer - QA
Sidmak Laboratories (India) pvt ltd.
Selaqui, Dehradun
10.2015 - 01.2019
- Executed tasks in transdermal manufacturing with exceptional precision.
- Contributed significantly to batch execution procedures.
- Achieved compliance during USFDA and Perrigo audits.
- Maintained consistent high performance within regulated environments.
Chemist - QA
Kalindi Medicure Laboratories pvt ltd.
Selaqui, Dehradun
01.2015 - 10.2015
- Achieved exemplary performance in all assigned tasks.
- Successfully passed WHO-GMP audit with no discrepancies.
- Managed rigorous audits for renowned companies, including Abbott, Dr. Reddys, and Cipla.
- Oversaw audits of Sanzymes, Unichem, and Lupin to ensure compliance standards.
Education
Master of Pharmacy- Bronze Medalist - Pharmacology
Uttarakhand Technical University
Dehradun01-2014
Bachelor of Pharmacy - Pharmaceutical Sciences
Sardar Bhagwan Singh, PGI, Balawala
Dehradun01-2012
Senior Secondary -
Kendriya Vidyalaya
Raebareli01-2008
High School -
Kendriya Vidyalaya
Raebareli01-2006
Skills
Validation protocols and change control
Stratified sampling and statistical analysis
Microsoft Word and Excel
Risk management strategies
Time management techniques
Quality assurance and management
Corrective and preventive action (CAPA)
Learning management systems
Cleaning validation processes
Calibration methods
Time study analysis
Process validation practices
Batch record review
Languages
English
Upper Intermediate (B2)
B2
Hindi
Native
Native
Timeline
Sr. Executive- QA
Sun Pharma
04.2021 - Current
Team Member - QA
Dr. Reddy's Laboratories Ltd. FT06
01.2019 - 03.2021
Officer - QA
Sidmak Laboratories (India) pvt ltd.
10.2015 - 01.2019
Chemist - QA
Kalindi Medicure Laboratories pvt ltd.
01.2015 - 10.2015
Master of Pharmacy- Bronze Medalist - Pharmacology
Uttarakhand Technical University
Bachelor of Pharmacy - Pharmaceutical Sciences
Sardar Bhagwan Singh, PGI, Balawala
Senior Secondary -
Kendriya Vidyalaya
High School -
Kendriya Vidyalaya