A Senior Executive in Biocon Biologics and research associate in Aurigene oncology limited., I have completed my MSc in Biochemistry and certification in pharmacovigilance to ensure quality compliance and validation of computer systems and products in the biopharmaceutical industry.I contributed to the authoring and reviewing of CSV deliverables, SOPs, protocol deviations, risk assessments, and validation reports, following the 21 CFR part 11 and GxP FDA regulations. I also handled the investigations of QMS, using various modes of RCA and implementing and completing effectiveness checks. Moreover, I gained experience in clinical data management, clinical research, and regulatory affairs, using databases such as RAVE, INFORM, and MedDRA, and following the ICH-GCP guidelines.My goal is to leverage my skills and knowledge in cGMP, eCTD, CSV, and pharmacovigilance to support the development and delivery of safe and effective biologics and biosimilars, and to collaborate with diverse teams and stakeholders in the fast-growing and dynamic biotechnology sector.