Dakshesh N. Patel

Quality Assurance and Compliance professional with 16+ years of experience across GMP-regulated pharmaceutical, biotech, and healthcare manufacturing environments in Canada, USA, UK, and India. ASQ-Certified Quality Auditor (CQA) with strong expertise in internal/external audits, batch release, QMS governance, data integrity, documentation control, and regulatory inspection readiness (FDA, Health Canada, EU-GMP, MHRA). Proven ability to lead quality teams, strengthen compliance frameworks, and support continuous improvement initiatives across global operations.

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.

Master of Science - Pharmaceutical Science - Kingston University London (2010)

Bachelor of Pharmacy - Pharmacy - KBIPER, Gujarat University (2005)

Diploma in Pharmacy - Pharmacy - LMCP, Gujarat University (2002)