Darshan Patel
Ahmedabad
Summary
Experienced and results-driven Quality Assurance Manager with a strong background in pharmaceutical injectable manufacturing, specializing in sterile and parenteral dosage forms. Proven expertise in deviation investigation, CAPA implementation, regulatory compliance, and market complaint resolution. Demonstrated ability to streamline quality processes, ensure data integrity, and maintain high standards of GMP compliance. Actively contributed as a Subject Matter Expert (SME) during regulatory inspections.
Overview
16
16
years of professional experience
Work History
QA Assistant General Manager
Biotech vison Care Pvt.Ltd
Ahmedabad
07.2026 - Current
- Regulatory compliance: Enforce adherence to global standards like current Good Manufacturing Practices (cGMP), ISO 13485 (medical devices), and EU MDR, 21 CFR Part 820.
- Audit Management: Lead plant audits and face inspections by regulatory bodies (USFDA, ISO, CDSCO).
- QMS Oversight: Direct Corrective and Preventive Actions (CAPA), change controls, and risk management (ISO 14971).
- Team Leadership: Mentor and manage plant QA team and drive a culture of compliance.
- Validation & Review: Oversee process validation, equipment qualification, and batch release.
QA Manager
Emcure Pharmaceutical Limited
Ahmedabad
01.2020 - 06.2026
- Conducted thorough investigations of market complaints and deviations for both the General Parenteral and Oncology blocks at Emcure’s Sanand facility, implementing effective corrective and preventive actions (CAPA).
- Collaborated with cross-functional teams to drive timely and conclusive investigations.
- Managed field alert report submissions and product recall processes across two manufacturing blocks.
- Accountable for the timely preparation and submission of trend analysis reports related to market complaints and deviations.
- Acted as Subject Matter Expert (SME) during regulatory inspections, representing the investigation function.
- Oversaw the tracking and closure of corrective actions involving customers, suppliers, contract givers, and internal plant operations.
Deputy Manager QA
Aculife Healthcare Pvt. Ltd.
Ahmedabad
09.2019 - 01.2020
- Led a cross-functional team for an EU-focused group project, effectively delegating tasks and monitoring progress to ensure timely completion.
- Identified and resolved discrepancies proactively ahead of the EU inspection, ensuring compliance and readiness.
- Coordinated closely with the EU consultant for comprehensive pre-audit preparations.
- Designed workflow structures for the Quality Management System (QMS) module within QMS software, enhancing operational efficiency.
- Conducted risk assessments and escalated identified gaps to senior management for prompt action.
Senior Executive QA
Sun Pharmaceutical Industries Limited
Vadodara
07.2016 - 07.2019
- Accountable for investigating, reviewing, and approving deviations in compliance with quality standards.
- Prepared and maintained Standard Operating Procedures (SOPs) to support consistent operational practices.
- Served as a reviewer and approver for Quality Management System (QMS) documentation and processes.
- Managed training programs, ensuring effective implementation and compliance with regulatory requirements.
- Conducted risk assessments and implemented Corrective and Preventive Actions (CAPA) to mitigate potential issues.
Assistant Manager QA
Zydus Pfizer Oncology Pvt. Ltd.
Ahmedabad
09.2011 - 07.2016
- Reviewed batch manufacturing and packing records to ensure compliance with GMP and regulatory standards.
- Prepared Standard Operating Procedures (SOPs) to support consistent and compliant operations.
- Oversaw batch release activities, ensuring timely and accurate product disposition.
- Reviewed analytical data for raw materials and secondary packaging materials to verify quality and specification adherence.
- Investigated market complaints, identifying root causes and implementing appropriate corrective actions.
Sr. Chemist QA
Concord Biotech Limited
Dholka
09.2010 - 09.2011
- Prepared Annual Product Quality Review (APQR) reports to ensure ongoing product quality and regulatory compliance.
- Managed issuance and control of GMP documents, maintaining version control and document integrity.
- Reviewed batch manufacturing and packing records for accuracy and compliance with established procedures.
Education
Master of Science - Biotechnology
University of Hertfordshire
United Kingdom08.2010
B.Pharmacy -
North Gujarat Patan University
Mehsana06.2006
Skills
- QMS software implementation and handling
- Audit management and compliance
- Market complaint investigations
- Risk assessment
- Trend analysis
- Deviation investigation and CAPA
- GMP and regulatory compliance
Languages
- English
- Hindi
- Gujarati
Personal Information
Nationality: Indian
Quality Assurance
Quality Assurance Manager
Timeline
QA Assistant General Manager
Biotech vison Care Pvt.Ltd
07.2026 - Current
QA Manager
Emcure Pharmaceutical Limited
01.2020 - 06.2026
Deputy Manager QA
Aculife Healthcare Pvt. Ltd.
09.2019 - 01.2020
Senior Executive QA
Sun Pharmaceutical Industries Limited
07.2016 - 07.2019
Assistant Manager QA
Zydus Pfizer Oncology Pvt. Ltd.
09.2011 - 07.2016
Sr. Chemist QA
Concord Biotech Limited
09.2010 - 09.2011
Master of Science - Biotechnology
University of Hertfordshire
B.Pharmacy -
North Gujarat Patan University