- Coordinating with CFTs, CMOs, and other stakeholders ensuring smooth functioning and execution of relevant activities.- Handling of QMS elements like change control, CAPA, deviation, OOS, OOT, incidents, and Market complaints.- Preparation of APQR, SOP, study protocols, and reports. - Ensuring overall lab Compliance, cGMP Compliance, AMV, stability studies.

- cGMP Compliance and Monitoring of overall QC Analytical activities- Active participation in external, and internal audits as an SME.- Review of Computer system validation reports.- Audit trail review of Empower 3, Chromeleon, Spectramanager, Refractosoft, Lab Solutions softwares.- Review of Analytical Method Validation protocol and reports, Stability Study protocol and reports, hold time study protocol and reports, and other study reports.- Investigation, handing, and… Show more - cGMP Compliance and Monitoring of overall QC Analytical activities- Active participation in external, and internal audits as an SME.- Review of Computer system validation reports.- Audit trail review of Empower 3, Chromeleon, Spectramanager, Refractosoft, Lab Solutions softwares.- Review of Analytical Method Validation protocol and reports, Stability Study protocol and reports, hold time study protocol and reports, and other study reports.- Investigation, handing, and closure of Incidents, OOS, OOT, OOC, and deviations.- Review and approval of FP and stability reports etc.- Review and approval of SOPs, Specifications, and STPs- Handling of change control, CAPA and other QMS elements. Show less

- Review of Analytical Method Validation protocol and reports, Stability study protocols, and reports.- Review of Equipment/instrument qualification and calibration reports.- Review of computer system validation reports.- Review of analytical reports and release of SFG & FG in SAP system.- Investigation, handing, and closure of Incidents, OOS, OOT, OOC, Change Control, and deviations.- Review and approval of study protocols and reports.- Preparation of APQR, OOT trend… Show more - Review of Analytical Method Validation protocol and reports, Stability study protocols, and reports.- Review of Equipment/instrument qualification and calibration reports.- Review of computer system validation reports.- Review of analytical reports and release of SFG & FG in SAP system.- Investigation, handing, and closure of Incidents, OOS, OOT, OOC, Change Control, and deviations.- Review and approval of study protocols and reports.- Preparation of APQR, OOT trend reports, etc. Show less

- Review of Analytical Method Validation protocol and reports, Stability study protocols, and reports.- Review of Equipment/instrument qualification and calibration reports.- Review of computer system validation reports.- Review of analytical reports and release of SFG & FG in SAP system.- Investigation, handing, and closure of Incidents, OOS, OOT, OOC, Change Control, and deviations.- Review and approval of study protocols and reports.- Preparation of APQR, OOT trend… Show more - Review of Analytical Method Validation protocol and reports, Stability study protocols, and reports.- Review of Equipment/instrument qualification and calibration reports.- Review of computer system validation reports.- Review of analytical reports and release of SFG & FG in SAP system.- Investigation, handing, and closure of Incidents, OOS, OOT, OOC, Change Control, and deviations.- Review and approval of study protocols and reports.- Preparation of APQR, OOT trend reports, etc.- Audit trail review of Empower 3,Chromeleon, Spectramanager, Refractosoft, Lab Solutions softwares. Show less

- Review of stability study protocols and reports.- Review of FP reports.- Handling of HPLC, GC, qPCR, UV spectrophotometer, pH meter- Performing lab monitoring, cGLP checks at QC Biological lab.

- Performing Environmental monitoring.- Calibration of different instruments.- Water testing