Naresh A Raikot

Sr Manager Qa @Enaltec Labs Pvt Ltd

Mumbai, IN

Led and managed the R&D formulation QA team for regulated and semi-regulated markets and USFDA approved CTL.Conceptualized the establishment of a GMP pilot BE manufacturing facility for Oncology OSD products.Streamlined the reporting of KPIs and shared comprehensive Monthly/Quarterly QRM updates with management.Ensured sites were audit-ready for clients and regulatory inspections, conducting detailed gap assessments & DI Preparation.Assessed vendor qualifications and conducted thorough audits for API manufacturing, CMO, and contract testing laboratories along with Quality Technical Agreement.Supervised and sanctioned quality activities and technology transfer processes.Coordinated and provided support to the RA team for DCGI/USFDA submissions and managed regulatory queries effectively.Supervise investigation, review and approval of QMS documents such as, OOS, Incident, Deviation, CAPA & Change control.Supervise, review and approval of Analytical Method Validation Protocol/Reports, calibration data, batch release data, Qualification Protocol/ Reports and stability protocol/data, Specification and STP.Supervise, review and approval of Product Development Reports (PDR), Batch Manufacturing Reports (BMR), Master Formula Cards (MFC) and other related documents related to technology transfer of formulation and analytical dept for OSD and Injectable Dosage form & Oncology Dosage for Tablets.Facilitated team training and development initiatives, ensuring effective communication and collaboration within the team

MSc in Chemistry

Master of Science (MSc) from Madurai Kaamraj University

Jhunjhunwala college Vintage Point

Diploma in Regulatory Affairs