jaskiran kaur
@jaskirankaur
Quality Operations Specialist improving GMP quality systems through batch review, compliance, and CAPA-driven problem solving.
IndiaWhat I'm looking for
I’m a Quality Operations Specialist with over five years of experience in batch record review, regulatory compliance, and GMP-based quality systems in the pharmaceutical industry. I focus on keeping documentation accurate, timely, and audit-ready while supporting smooth product release.
In my current role at Sandoz, I manage batch record review across multiple stakeholders by coordinating with suppliers and global manufacturing sites. I handle QMS activities across GxP and non-GxP areas, including deviations, issue logs, and OOS investigations—driving timely CAPA closure per standard procedures.
I also lead knowledge transfer as a certified trainer, helping new team members build the capability needed for a smooth handover. Alongside team leadership, I contribute to onboarding of new services and process changes, and I look for process improvements that keep procedures consistent across teams.
Previously at Sandoz and Novartis, I conducted regulatory compliance checks, reviewed artworks and labels, and prepared and reviewed APQRs and MAH reports. I supported internal and external audits by pulling required data and documents, and I consistently tracked quality and timeliness KPIs while generating insights using tools like SAP, Agile PLM, AQWA, Trackwise, and GLORIA.
Experience
Work history, roles, and key accomplishments
Managed batch record review across multiple stakeholders, coordinating with suppliers and global manufacturing sites to keep documentation on schedule. Led QMS activities across GxP/non-GxP areas, including deviations and OOS investigations, and drove timely CAPA closure while delivering knowledge transfer as a qualified trainer.
Reviewed certificates of conformance and analysis against registered specifications as part of batch record review, and ensured artwork and labels met accuracy and compliance requirements. Created team workflows and working procedures, helping streamline review processes to improve turnaround time and customer satisfaction.
Performed regulatory compliance checks and batch record reviews using defined procedures in a cGMP environment. Supported internal and external audits, created and reviewed GxP documents aligned to ALCOA+ principles, and prepared APQRs/MAH reports while tracking quality and timeliness KPIs.
Trained through the company’s JUMPSTART program to perform regulatory compliance checks before and after manufacturing, including review of CoC/CoA against specifications and regulatory requirements. Tracked quality and timeliness KPIs across operations to support performance targets.
Education
Degrees, certifications, and relevant coursework
UIPS, Panjab University
Master of Pharmacy, Pharmaceutical Analysis
2018 - 2020
Completed a Master of Pharmacy with a focus on pharmaceutical analysis at UIPS, Panjab University, Chandigarh.
Chitkara University (Punjab)
Bachelor of Pharmacy, Pharmacy
2014 - 2018
Completed a Bachelor of Pharmacy at Chitkara University in Punjab.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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