Atul Jagtap
Pune
Summary
I've specialized in Quality Management System (QMS) across three different reputed MNC organizations, focusing on manufacturing compliance. Currently, I am leveraging this expertise as Senior associate in computer system Validation compliance at cognizant. My career progression showcases a deep understanding of pharmaceutical regulations, quality assurance and role in data integrity in GxP environment. I'm skilled in ensuring adherence to global standard and bridging the gap between quality practices and technology implementation to maintain high- quality and compliant operations.
Overview
10
10
years of professional experience
Work History
Senior Associate
cognizant
Pune
07.2024 - Current
- working as operational compliance manager for Novartis clint for workday application.
Senior Executive
Biocon
benguluru
08.2021 - 06.2024
- QUALITY MANAGEMENT SYSTEM:
Incident, deviation Investigation & CAPA creation in trackwise, report preparation and assigning disposition of batches associated to incidents (Product, OOL, OOS, OOT, Process, Equipment, Software, Utility, Procedural and Area) - Review of URS, DQ, IQ, OQ and PQ documentation as per 21CFR part 11 and GAMP 5 compliance.
Senior Associate
Mylan
benguluru
09.2018 - 08.2021
- Quality management system: Deviation investigation, change control, CAPA management, Market complaint investigation.
Officer
Cipla
Goa
02.2016 - 09.2018
- Batch manufacturing
- BMR review
- SOP preparation
- Participation in qualification task
Education
B. Pharmacy - Pharmacy
SPM's College of Pharmacy
Akluj 06-2015
Skills
- CSV compliance
- Operational compliance
- Deviation investigation
- Regulatory documentation
- Root cause analysis
- CAPA management
- Change control management
Timeline
Senior Associate
cognizant
07.2024 - Current
Senior Executive
Biocon
08.2021 - 06.2024
Senior Associate
Mylan
09.2018 - 08.2021
Officer
Cipla
02.2016 - 09.2018
B. Pharmacy - Pharmacy
SPM's College of Pharmacy