- Experience in review of analytical data w.r.t. raw material and Finished drug products (Oral solids).
- Experience in review and evaluation of process validation data , Analytical Method Validation/verification/ transfer protocol, reports and data.
- Experience in review and evaluation of stability study trends.
- Should have sufficient skills and handling experience for SAP , instrumental softwares (Empower, Chromeleon),
- Experience in review of analytical data w.r.t Qualification, CSV and Calibration related documents for laboratory instruments.
- Experience of handling/documentation related to OOS, OOT, OOC, Deviations and Laboratory events /incidences.
- Should have sufficient knowledge of CGMP,ICH guidances& other regulatory guidances. Should be aware with regulatory requirements and updates.
- Should be proficient in English ( preferably writing with grammatical awareness).
📌 AQA Reviewer (Pune)
🏢 Emcure
📍 Pune