1) To review Analytical Method Validation, Analytical Method Trasfer Protocols, data and reports. 2) Stability Management, Monitoring and management of Stabiolity chambers and its reports. 3) Responsible For Internal Audits and its compliance. 4) Responsible for management of archival documents. 5) Responsible for management of documents for RA Submission. 6) To review and maintenance of Master Excel Sheets. 7) To review Audit Trail of Chromatographic and Non Chromatographic Software. 8) Management of Documents and their Control, Issuance of Controlled Sheet, Logbook and LNB. To maintain and issue ATR /Worksheets. 9) To review of QMS document like Change Control, incident, OOS/OOT/OOC and CAPA. 10) Responsible for external laboratory audits and its compliance. 11) To review Analytical data, COA Specification, MOA,Analyst Qualification and ATR of Raw Material, Packaging Material, Finished Product and In process 12) Preparation and review of SOPs and maintenance of same.
