Shreya Naik

Developing and updating process design protocols, process qualifications protocols, stability protocols, master formula records, and bill of materials. Handling quality management systems including change controls, deviations, and risk assessments, and managing SAP and Trackwise activities.

Ensured regulatory compliance by maintaining and updating product dossiers, managing lifecycle variations, and overseeing regulatory documentation. Liaised with R&D for product registration and prepared site-specific master formula records and validation protocols for technology transfer.

Provided regulatory support, coordinated FDA/CDSCO licenses and product approvals, and drafted critical GMP documentation. Managed change controls, deviations, and CAPAs, conducted self-inspections, and spearheaded validation and qualification activities.

Implemented supplier qualification procedures, integrated quality assurance into procurement, and managed change controls and deviations. Oversaw technical agreements with clients and developed SOPs to reduce non-compliance incidents.

Conducted floor level quality checks to ensure cGMP compliance, reviewed batch manufacturing records, and facilitated document issuance to departments.

Interpreted and dispensed medications accurately, offered personalized advice, and oversaw controlled dispensing to ensure compliance and patient safety.

Bachelor of Pharmacy degree from PES’s Rajaram And Tarabai College of Pharmacy in Goa.