Ojaswini Vishvanath Nemade

• Prepared and reviewed regulatory dossiers (DMF, ANDA, API submissions) in line with USFDA and WHO requirements.
• Actively supported regulatory audits (USFDA, WHO, ZAMRA) ensuring full compliance with zero critical observations.
• Collaborated with R&D and QA teams to prepare regulatory strategies for new product development.
• Ensured timely responses to queries from regulatory authorities, reducing approval delays by 15%.

Executed line clearance procedures at dispensing, manufacturing, and packing stages.
Conducted IPQA checks during granulation, compression, coating, capsule filling, blister packing, strip packing, and secondary and tertiary packing.
Performed IPQA checks throughout liquid manufacturing, bottle filling, and sealing processes.
Implemented IPQA checks during ointment manufacturing and tube filling operations.
Reviewed batch manufacturing records (BMR) and batch packaging records (BPR).
Prepared and issued formats for documentation review.
Developed and reviewed standard operating procedures (SOPs) to ensure compliance.
Managed quality assurance documentation to maintain regulatory standards.