Manish Gajjar

Experienced API Manufacturing professional with 34 years in Active Pharmaceutical Ingredients production. Associated with Ranbaxy Laboratories Ltd./Sun Pharma for 22 years and Ipca Laboratories Limited for 11 years. Expertise in multi-product facility plant API, production department management, plant start-up and commissioning. Proficient in handling deviations, investigations, out of specification cases, and ensuring GMP compliance and regulatory requirements.

Production Department - API Manufacturing - Ranbaxy Laboratories Ltd./Sun Pharma - Dewas

(1992-01 - 2025-01)

Associated with Management for 22 years. Functioning for production department, plant start-up and plant commissioning, API and Intermediate manufacturing.

• Handled multiple pharmaceutical products including Ciprofloxacin, Gabapentin, Etodalac, Acyclovir, Gancyclovir, Valacyclovir, Valgancyclovir, Valsartan, Telmesartan, Orlistat, Clarithromycin, Citalopram, Cephalexin, and Antimalarial drugs
• Managed all market requirements as per product specifications
• Handled all Deviation, Investigation, Out of specification, and out of trend tracking
• Applied Standard Operating Procedures for production system, Validation system, and Good Documentation Practices
• Managed production department quality, production targets, and GMP maintenance
• Active involvement in process control and by-product recovery for cost reduction
• Ensured 100% compliance to statutory requirements of EHS
• Ensured compliance during internal and external audits

Production Department - API Manufacturing - Ipca Laboratories Limited - Indore/Dewas

(1992-01 - 2025-01)

Associated for 11 years. Functioning for production department, plant start-up and plant commissioning, API and Intermediate manufacturing.

• Handled multiple pharmaceutical products including Ciprofloxacin, Gabapentin, Etodalac, Acyclovir, and other Active Pharmaceutical Ingredients
• Managed production operations and quality assurance
• Maintained regulatory and non-regulatory documentation for domestic and international markets
• Participated in audit preparation for different regulatory authorities and customers

Production Department - API Manufacturing - CTX Life Science

(1992-01 - 2025-01)

Active Pharmaceuticals manufacturing Production department experience

M.Sc. - Organic Chemistry - Gujarati Sciences College, Indore, Devi Alhya Vishwa Vidyalaya (M.P) (1989)

B.Sc. - Holkar Sciences College, Indore, Devi Alhya Vishwa Vidyalaya (M.P) (1987)

HSC - ST. Paul Higher Secondary School, Indore (1984)