Bajarang Wagh

Quality and Analytical Development leader with 21 years in regulated pharmaceuticals. Drives GMP compliance, laboratory operations, change control, audit readiness, and analytical standards management while leading cross-functional teams and scientific personnel.

Quality Head - Savvycare & Cosmetics Pvt. Ltd - Rabale Navi Mumbai (USFDA/NSF approved site)

(2025-12)

• Leads site quality oversight across manufacturing and laboratory operations, maintaining cGMP compliance and audit readiness
• Directs change control, document review, and investigations for OOS, OOT, deviations, and incidents through CAPA closure
• Approves lifecycle quality documentation, including Site Master Files, Validation Master Plans, SOPs, BMRs, and APQRs

GMP Quality Auditor & Consultant - GXP Consultant - Mumbai

(2024-10 - 2025-12)

• Audited vendors, CMOs, and laboratories across India and China to assess GMP compliance and identify improvements
• Advised pharmaceutical companies on GMP quality requirements and technical compliance

Manager, Quality Assurance EM - Sanofi EM - Mumbai

(2023-04 - 2024-08)

• Implemented Veeva-Vault QMS requirements for third parties, events, change controls, deviations, and product complaints
• Led CMO risk rankings, compendial surveillance, and Nitrosamine & NDSRI assessments for drug substances and products
• Managed Quality Agreements and CMO and supplier audits while supporting continuous improvement and technology transfers

Manager, Analytical Development and Quality Control - Sanofi - Goa

(2008-07 - 2023-03)

• Led and mentored 10 analysts in analytical development and QC, strengthening cGMP, GLP, data integrity, and technical capabilities

Sr. Executive - Quality Control - Dr. Reddy's Laboratories - Hyderabad (USFDA/MHRA approved site)

(2006-09 - 2008-07)

• Managed reference, working, and impurity standards; reviewed QC records and supported global regulatory audits

Quality Control - Officer - Lupin LTD - Goa (USFDA/MHRA approved site)

(2005-05 - 2006-08)

• Supported product sampling and release, contributing to USFDA and MHRA audit readiness and execution

Master of Science - Organic Chemistry - Shivaji University Kolhapur (2004)