- Review of RM, PM, SFG, FG, Stability, In-process stage, Cleaning validation, In-process validation, documents related to events like OOS, Incident, OOT, Reanalysis, hypothesis analysis, water analysis, environment monitoring reports, trends, calibrations, instrument verification, working standards.
- Approval of SFG, FG, Stability, In-process stage, Cleaning validation, In-process validation, documents related to events like OOS, Incident, OOT, Reanalysis, hypothesis analysis, setting monitoring reports, trends, calibrations, instrument verification, working standards.
- Review and approval for the On-line activities like Sample set methods, sequences, standalone instruments data, time events, volumetric solution preparation records.
- Requests approval in SAP for Reprint requests, error logs, extra copy prints through SAP as per requests of reprints of TDS.
- Review in SAP for RM, PM, SFG, FG(Review only), Stability, water, calibrations data.
- Approval in SAP for SFG, FG(Review only), Stability, calibrations data.
- Sign off2 for Standalone instruments and HPLC/GC.
- Reconciliation of Standalone instruments, HPLC, GC for analytical data.
- Filing and SAP e-register entries of Stability Data, and submission of data in Documentation cell.
- Quarterly review of QC lab Log books.
- Review / closure of e log book entries related to analysis, instruments usage, working standard consumption, chemical usage entries.
- Manual COA preparation,



checking and approval for SFG and FG as per requirements.
- Reconciliation of B type SOP formats through SAP.
- To complete the training assigned in ASPIRE and To attend the routine training assigned.
- To verify and check the number of samples for analysis (chemical and micro) received in stability section.
- To prepare, review and check the trends of FG/SFG by mini-tab.
- To review, check and approve the CSV and AMV protocols and reports.
- To follow any other instruction given by reporting authority or department head.
- To review and approve the electronic data of stability chamber in ICDAS application software.
- Approval of TDS, Protocols and reports, SOP formats In Open text.
- Completion of tasks In Track-wise related to LER, CFT, OOS, OOT, CAPA, CC, incidents.
- Execution and completion of Code to code tasks assigned to AQA in SAP for RM, PM, SFG 23. Investigation and documentation for events related of Data Mining observation for AQA team members.
- To perform monthly review of standalone and chromatographic system in data mining activity. 25. 100% verification of released plates of MLT, AET , EM , Water , Rinse/ Swab on colony counter as well as pathogen plates.
- Water and EM trend review and approval.
- Handing and reconciliation of Placebo.
- Storage, reconciliation and destruction of Nasal SFG stage sample..

📌 Senior Officer (Baddi)
🏢 Glenmark Pharmaceuticals
📍 Baddi