Document Reviewer - BIORESEARCH LABORATORY

Role Overview: You will be working as an Executive - QC in the Small Molecule Bioanalytical Research Laboratory at Syngene International Ltd. in Bangalore, India. Your main responsibility will be to review data for BA/BE studies in the laboratory, including checking method development, validation, and sample analysis data. You will report to the Head / Group Leader of the Small Molecule Bioanalytical Laboratory. Key Responsibilities: - Perform data checks (QC) for method development, validation, and study sample analysis. - Review STPs, Protocols, validation, and bioanalytical reports. - Ensure necessary documents and records are updated and ready for audits (Sponsor / Regulatory). - Handle Change Management, initiate change requests as needed. - Conduct daily and monthly inspections in the Bioanalytical Research Laboratory when required. - Ensure all studies comply with regulatory guidelines and expectations set by GCP/GLP. - Discuss QC observations with the Project Leader / Group Leader / Head, BRL for corrective actions and verify the corrective actions. - Prepare QC observation trend analysis and discuss with management on a scheduled basis. Qualification Required: - Education: M. Pharm / B. Pharm / M.Sc. in Pharmaceutical Sciences / Analytical chemistry or other related life sciences from a reputed university. - Industry Experience: Minimum of 3 years of experience in regulated small molecule bioanalysis. Hands-on experience in small molecule regulated bioanalytical experiments. - Exposure And Experience: Experience working for a Bioanalytical CRO lab will be an added advantage. Additional Company Details: Syngene International Ltd. is an integrated research, development, and manufacturing solutions company serving various sectors. With a team of over 4500 scientists and specialist facilities, Syngene aims to deliver great science, robust data management, and quality manufacturing to improve time-to-market and lower the cost of innovation. Visit https://syngeneintl.com/ to learn more about the company and its activities.,