- Responsible for reviewing Specifications, Standard Test Procedures & ADS of Raw materials, In-process, Intermediate and Finished drug substances, Packing materials, Stability and Retest materials.
- Responsible for involving in Method validation activities & reviewing of Analytical method validation protocol and reports
- Responsible for reviewing Hold-time study and Stability Protocols, Reports & its compilation data.
- Responsible for assessment, classification, final review and closure of Change controls.
- Monitoring all in process analysis and monitoring all CCPs as per the BMR.
- Review and approval of SOPs, BMR, Specifications, Protocols & other quality documents (In the absence of QA-Head).
- Responsible for checking the SOP and to ensure proper implementation of the system as per SOP in QC laboratory.
- Daily monitoring of QC Day to day activities.
- Review of all instruments calibration reports.
- Preparation/Review/Approval of COAs.
- Audit preparation for customer/Regulator requirement.
- Knowledge of Regulatory guidelines like ICH, USFDA, MHRA, EUGMP.
- Review of instrument software for audit trail and 21 CFR compliance