General Manager – Quality Assurance - Lark Laboratories(India) Ltd. - Bhiwadi, Rajasthan
(2024-10)
Accomplished Quality Assurance and Regulatory Compliance professional with extensive experience in managing and driving end-to-end Quality Management Systems (QMS) in compliance with global regulatory standards. Demonstrated expertise in overseeing key QMS elements such as Change Control, Deviations, Incidents, Market Complaints, Recalls, OOS, Investigations, and CAPA, with a strong focus on timely resolution and regulatory alignment.
- Proficient in implementing and sustaining robust Quality Systems, executing comprehensive validation activities (including process, cleaning, HVAC, and area qualifications), and ensuring the use of qualified starting materials, packaging components, and in-process controls.
- Adept at ensuring product release compliance, conducting risk-based quality reviews, and enforcing documentation integrity across operations.
- Expert in managing internal audits, supporting external regulatory inspections, and driving CAPA closures in coordination with cross-functional teams.
- Skilled in stability data evaluation, change control impact assessments, and lifecycle management of quality documents including SMF, VMP, SOPs, protocols, and master records.
- Strong command of product lifecycle management—from R&D transfer to commercial scale-up—ensuring critical quality attributes and regulatory expectations are met.
- Leads initiatives in hygiene and sanitation compliance across warehouse, production, and laboratory settings, with direct oversight of quality-related training in GMP and data integrity practices.
- Effectively handles regulatory audits, prepares compliance reports, and coordinates with global regulatory agencies for dossier submissions, variation filings, and responses to Ministry of Health queries.
- Plays a pivotal role in complaint management and post-market surveillance, leveraging root cause analysis and CAPA to enhance consumer satisfaction.
- Experienced in SAP-based batch release processes, regional budget preparation, and financial monitoring.
- Committed to building a strong quality culture across business units and commercial functions, while continuously improving systems to maintain a state of control and operational excellence
Site Quality Head (GM) - Galpha Laboratories Ltd. - Baddi, H.P
(2024-03 - 2024-08)
- Led QA/QC operations with 95+ professionals
- Ensured EU-GMP & MHRA audit readiness
- Strengthened QMS effectiveness, CAPA systems, and investigations
- Improved compliance efficiency and reduced repeat deviations
- Successfully cleared Ukraine Regulatory Audit within 6 months of joining the organization, demonstrating rapid system stabilization, strong inspection readiness, and effective leadership under regulatory scrutiny
- Achieved successful audit closure without re-inspection requirement, ensuring uninterrupted compliance status
Head – QUALITY ASSURANCE & AQA (AGM) - Kusum Healthcare Pvt. Ltd. - Bhiwadi, Rajasthan
(2016-01 - 2024-02)
Headed Quality Assurance, AQA, Validation, and Data Integrity functions for a multi-site pharmaceutical organization, ensuring compliance with EU-GMP, WHO-GMP, and global regulatory standards. Led complete end-to-end QMS ownership, including regulatory inspections, system remediation, digital transformation, and quality culture development across the organization.
- Full ownership of QMS lifecycle management: CAPA, Deviation, OOS/OOT, Change Control, Complaints, Recalls
- Led global regulatory inspections and audit readiness programs (EU/WHO/International agencies)
- Managed process, cleaning, HVAC, and equipment validation programs
- Oversaw data integrity (ALCOA+) compliance and system governance
- Directed technology transfer and product lifecycle quality assurance
- Ensured compliance in batch release, stability studies, and APQR/PQR systems
- Managed cross-functional coordination between QA, QC, Production, and R&D
- Successfully cleared EU GMP with 0 critical & 0 major observations
- Delivered consistent regulatory compliance across multiple global inspections (EU, WHO, and international agencies)
- Implemented digital QMS transformation (Caliber QAMS/DMS) improving documentation efficiency by ~40%
- Implemented CLEEN system for cleaning validation compliance and control
- Achieved zero product recalls during entire tenure at Kusum Healthcare
- Strengthened data integrity systems with zero DI-related audit observations in audit
- Led successful remediation and CAPA closure programs across multiple regulatory inspections
- Built and strengthened company-wide quality culture and GMP compliance system
- Recognized as key driver of audit excellence and regulatory compliance stability
- Played critical role in transforming QA systems into a proactive, risk-based quality model
- Built strong cross-functional alignment between QA, QC, Production, and R&D
Dy. Manager – Corporate QA - Akums Drugs & Pharmaceuticals Ltd. - Haridwar
(2014-04 - 2015-12)
- Led multi-site regulatory compliance and audit readiness
- Approved validation protocols and QMS systems
- Conducted GAP analysis and CAPA implementation
Sr. Lead – QMS - Zydus Cadila Healthcare Ltd. - Baddi, H.P
(2008-05 - 2014-04)
- Managed QMS, APQR/PQR, USFDA inspections, and regulatory compliance
- Led deviation, complaint, recall, and CAPA systems
- Preparation of AUDIT Compliance of report for all Audit
- Market complaint, recall and their investigation with CAPA
- Preparation of Annual trend of Deviation, Change Control and Complaint
Executive QA - Alembic Ltd. - Baddi, HP
(2006-03 - 2008)
QA - Biochem Pharma Industries Ltd - Daman, Gujarat
(2004-04 - 2006-03)
