Sunil Bhamare

Quality Leadership. Lead the quality and regulatory affairs organization for the site, Ensure the products exceed regulatory standards, quality and patient’s safety. Ensuring site’s 100% compliance with FDA, EMA, and Health Canada requirements. Strengthening Quality compliance for site, achieving zero major findings in regulatory audits. Leading Quality team (>80 people), making cultural transformation and building strong Quality culture. Exceeding client’s expectations by ensuring quality standards and timely deviation investigations, Batch release. Ensure site remains audit ready/compliant with FDA, Health Canada, EU and cGMP guidelines/state and federal laws. Monitoring KPIs-Quality Metrics/ trends, gap/risk assessments/identify mitigation plans via FMEA, HACCP, etc. Partnered with various cross-functional groups to harmonize best practices across sites, driving consistency and efficiency and End-to-End process. Supported as CDMO for qualifying equipment/process, End-to-End process. Leading Client’s, regulatory inspections - FDA, Health Canada and other international regulatory agencies.

Driving sterility assurance and regulatory excellence by leading QA teams, strengthening aseptic operations, and championing global best practices to keep products safe and sites audit-ready.

Led quality systems improvements, change management, and regulatory compliance while overseeing audits, investigations, and product disposition to ensure sterile manufacturing excellence and global regulatory readiness.Led QA oversight for aseptic filling, packaging, and labeling, directly contributing to successful FDA and EU inspections with no critical observations. Enhanced QA review process, reducing deviation closure time by 40%, improving compliance and releases. Spearheaded data integrity upgrades (21 CFR Part 11 / Annex 1), ensuring readiness for inspections. Mentored QA and production teams on audit readiness, resulting in a 100% improvement in inspection. Review and approve GXP docs-Deviations, CAPA, Change Controls, SOP’s, Master Batch Manufacturing Documents.

Managed end-to-end validation for processes, equipment, and facilities (HVAC, water, clean utilities), including media fills, cleaning, and sterilization systems, while driving risk assessments, change management, and compliance with global regulations (US/EU/Canada, ISO 13485)

Senior RA/QA Associate – Managed product release, investigations, audits, and quality system improvements while supporting global regulatory submissions and ISO 13485 compliance.

Led audits, investigations, and quality system improvements while supporting process validations, change controls, and regulatory compliance across global operations.

Conducted 50+ internal and external audits, driving a 100% reduction in repeat deviations. Implemented robust CAPA and change management systems, improving audit scores year-over-year. Designed and delivered GMP training, increasing compliance awareness across the site. API quality oversight as per Q7A, approve APQRs, Vendor Change Controls, Sop’s, Master Batch records.

Supported batch record review, product release, deviations, CAPA, audits, and validation documentation to ensure compliance with GMP standards.

Microbiologist

Led QA/QC operations including microbiological testing, product release, method validation, and environmental monitoring while ensuring EU/US regulatory compliance. Directed audits, validations, and laboratory standards to strengthen sterile manufacturing and aseptic practices.

Led microbiology and stability testing of pharmaceutical products, prepared and approved SOPs and reports, supported regulatory submissions (FDA, TGA, EU), and participated in inspections while gaining hands-on experience with HPLC, GC, UV-VIS, and FTIR instruments.