Akanksha Gopale

About Akanksha Gopale

Pharma professional with 10 years of experience in Pharmaceutical Industry having core knowledge of manufacturing unit and Corporate quality assurance. Filed Patent against Research activities performed during Master in Pharmacy against Antimycobacterial activity of 1,2,4- Triazole derivatives and Thiazole derivatives. Expertise in the IPQA and QMS activities related to Solid oral dosage form, oral liquids, nasal sprays, topicals ( ointment, creams, rectal formulations). Expertise in the preparation of APQR, SOP\' s, MBMR, MBPR, HTS, Etc. Handled stability studies of above mentioned formulations. Involved in the Process validation of solid oral dosage forms. Efficiently dealing with 150+ Contract manufacturing sites for the QMS activities like Market complaints, Deviations, CAPA, Risk Assessment, Health hazard evaluation etc. with an accountability of Performing Investigation to get the RCA and CAPA from units, and closure of an investigation and involved in operational activities. Handling NSQ\'s/ FDA complaints. Faced WHO, TGA, Zambia, Peru, Phillipines, EU, Audits. Handling QMS activities in Track wise system and core responsibility of preparation Trending of complaints and deviations.

Experience

1. Senior Quality Operations Specialist

   Sandoz

   Jul 2025 — Present · Mumbai, IN

   Corporate Quality Assurance

Education

• Amrutvahini college of pharmacy, sangamner

  M.pharm, Medicinal and Pharmaceutical Chemistry

• Savitribai Phule Pune University

  Batchelor , Pharmacy