QA Associate-II - Piramal Healthcare Ltd. - Aurora, Ontario, Canada
(2022-09 - 2026-05)
- Executed batch disposition in compliance with GMP and regulatory expectations.
- Reviewed batch records, analytical documentation, SOPs, and controlled documents.
- Reviewed/approved deviations, change controls, CAPA, OOS, OOT, and quality events.
- Supported regulatory, client, and internal audits; prepared responses and ensured timely closure of actions.
- Conducted internal/external audits and provided cGMP oversight in manufacturing and QC labs.
- Participated in QMS programs including Change Control, CAPA, NonConformances, Vendor Qualification, Environmental Monitoring, and Quality Metrics.
- Delivered cGMP training and supported quality system improvement initiatives.
- Acted as designate for QA Manager and supported Data & Systems Review teams.
Quality Supervisor - Hexo Corp (formerly Zenabis Ltd.) - Atholville, New Brunswick, Canada
(2019-08 - 2022-06)
- Supervised Quality Management team; assigned tasks, monitored performance, and delivered training.
- Reviewed and approved deviations, quality events, change controls, CAPA, and OOS investigations.
- Investigated and managed product quality complaints, adverse reactions, and recall activities.
- Reviewed and approved SOPs, risk assessments, and batch records.
- Participated in product disposition and final release of products.
- Led internal audits (Self-Inspection) and participated in Health Canada and EU-GMP audits.
- Prepared audit responses and ensured timely closure of corrective actions.
- Managed site quality metrics and supported inspection readiness.
Assistant Manager - Quality Assurance - Zydus Hospira Oncology Ltd. (A Pfizer Company) - India
(2016-03 - 2019-03)
- Executed batch release with full decision-making responsibility, ensuring accuracy, compliance, and readiness for dispatch.
- Reviewed batch manufacturing records, Master Batch Records, validation documents, and qualification protocols (URS, DQ, IQ, OQ, PQ).
- Supported investigations and root-cause analysis for non-conformances.
- Released batches for dispatch and executed SAP release activities.
- Participated in regulatory inspections and prepared audit responses.
- Completed comprehensive APQRs, identifying quality trends and supporting proactive process and product improvements.
- Led QMS activities including deviations, CAPA, change control, and documentation review.
Officer - I, Quality Assurance - Unimed Technologies Ltd. (A Sun Pharma Company) - India
(2014-04 - 2016-03)
- Executed batch release with full decision‑making responsibility, ensuring accuracy, compliance, and readiness for dispatch.
- Reviewed batch manufacturing records, Master Batch Records, validation documents.
- Supervised IPQA team and ensured compliance during manufacturing and packaging operations.
- Conducted plant rounds, identified discrepancies, and recommended corrective actions.
- Supported process validation, cleaning validation, and sampling activities.
- Prepared monthly and quarterly quality reports for management review.
Executive - Quality Assurance - Sterling Biotech Ltd. - India
(2013-03 - 2014-04)
- Managed controlled documents, SOPs, batch records, and archival systems.
- Conducted IPQA checks, sampling, batch record review and batch release activities.
- Supported QMS elements including deviations, CAPA, OOS/OOT, and incident reporting.
- Participated in vendor qualification and validation oversight.
- Supported DMF filing and APQR review.
QA Assistant - Bristol Labs - United Kingdom
(2011-02 - 2012-07)
- Managed SOPs, controlled documents, and training programs.
- Supported regulatory inspections and compliance activities.
- Performed trend analysis for environmental monitoring and APQR data.
- Participated in internal audits and recommended CAPA improvements.
Executive - Quality Assurance - Alembic Ltd - India
(2006-06 - 2008-05)
- Oversaw quality systems in clinical research and bioanalytical divisions.
- Reviewed protocols, validation reports, calibration records, and raw data.
- Conducted retrospective audits and vendor/database audits.
- Maintained calibration planners, training records, and master lists.
