Manager – Analytical Data Reviewer

Key Responsibilities: Conduct thorough review of electronic analytical data generated by instruments like HPLC, GC, Dissolution Apparatus, and Malvern 3000 Evaluate laboratory data related to raw materials, intermediates, finished products , and stability studies Review and assess OOS, OOT, and lab incidents in compliance with cGMP and data integrity principles Support preparation and review of specifications, test methods, validation protocols/reports , and related documentation Perform data reviews through Empower, Chromeleon, OpenLab, LIMS, Lab Notebooks , and other relevant platforms Manage or support master data builds in LIMS (LabVantage / LabWare) Coordinate with cross-functional teams and provide support during regulatory audits and inspections Route and manage documentation in systems like eDMS or Ensur Contribute to QMS activities such as deviations, CAPAs, and change controls as required Required Experience & Skills: 8–14 years of experience in Quality Control / Quality Assurance within a regulated pharmaceutical environment Strong knowledge of analytical instrumentation and data review best practices Proficient in LIMS and electronic data review tools Experience in OSD and/or API processes is mandatory In-depth understanding of regulatory expectations (USFDA, EU, Health Canada, etc.) Sound knowledge of data integrity, GDP, and cGMP Excellent written and verbal communication, collaboration, and problem-solving skills Show more Show less