Manager - Quality (DDRC) - Analytical Data reviewer

As a remote analytical support personnel at PPL sites, your role involves reviewing analytical data and preparing various documents such as specifications, test methods, and protocols. You will be responsible for uploading documents for review in ENSURE and initiating QMS elements in TrackWise/eDMS. Additionally, you will prepare and review stability protocols and reports, and conduct stability data trending and analysis. Key Responsibilities: - Review analytical data generated in the analytical lab (QC/AS) including Cleaning verification data, IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data in accordance with cGMP, GDP, within specified timelines. - Check reports for accuracy and completeness, which may include method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc. - Have knowledge in analytical data review using Empower/Chromeleon/Open-Lab/Lab-Notebooks/LIMS/QMS module. - Develop and update working test methods compliant with compendia requirements to support analytical testing. - Manage Change Request Forms via the TrackWise system, including updates to product specifications and Certificates of Analysis (COA). - Perform trend analysis of release testing data to identify Out-of-Trend (OOT) results and establish procedures for trending and statistical data evaluation. - Review analytical data from external laboratories to ensure compliance with specifications and quality standards. - Share review deficiencies with the site team for further actions and participate in customer audits and regulatory inspections. - Lead and participate in any other tasks assigned by the Head of Department. Qualifications: - B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent degree Please note that this job is full-time and based at Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction, Mumbai, Maharashtra, 400070, IN.,