1.In Process Quality Assurance and System compliance: Perform line clearance activities in production Tablets and capsule area and propose corrective measures to prevent cross contamination. Monitoring & review of trial, exhibit, validation and commercial batches at each stage.  Verification of CCP generated printout (process data) like assay, calculation LOD recipe during execution of trial, Exhibit, validation and commercial batches. Review of executed submission /commercial batch BMR /BPR at each stage & verification of critical control point to facilitate timely release of SFG/FGTN. Perform AQL (Acceptance quality level) Sample collection of all Validation Batches including intermediate and finished product as per SOP/BMR/BPR/protocol. CGMP Compliance in Manufacturing department.2.Document Compliance: Co-ordination for internal /Customer/Regulatory audits & Compliance. Preparation & review of SOPs/WI, protocols, and reports. Software handle SAP, MES, Track wise, e-Validation, e-logbook. Preparation and review and approval of Method validation/Cleaning validation, Equipment Qualification protocol. Facilitate timely completion & effective implementation of QMS system deviation, change control, CAPA, OOS, OOT and market complaint.3.Quality Management System: Carry out failure investigation in case of product failures & resolution with implementation of CAPA. CFT/SME/Task review of deviation, change control, OOS, OOT, CAPA, Market Complaints  Conducting RCI and proposing CAPA action for failure. Effectiveness checks of implementation of CAPA.

1.In Process Quality Assurance and System compliance: Perform line clearance activities in production Tablets and capsules area, softgel block, OLT department and propose corrective measures to prevent cross contamination. Monitoring & review of trial, exhibit, validation and commercial batches at each stage.  Verification of CCP generated printout (process data) like assay, calculation LOD recipe during execution of trial, Exhibit, validation and commercial batches. Review of executed submission /commercial batch BMR /BPR at each stage & verification of critical control point to facilitate timely release of SFG/FGTN. Perform AQL (Acceptance quality level) Sample collection of all Validation Batches including intermediate and finished product as per SOP/BMR/BPR/protocol. CGMP Compliance in Manufacturing department. Execution and review of E-BMR and E-Logbook.2.Document Compliance: Co-ordination for internal /Customer/Regulatory audits & Compliance. Preparation & review of SOPs/WI, protocols, and reports. Software handle SAP, MES, Track wise, e-Validation, e-logbook. Preparation and review and approval of Method validation/Cleaning validation, Equipment Qualification protocol. Facilitate timely completion & effective implementation of QMS system deviation, change control, CAPA, OOS, OOT and market complaint.3.Quality Management System: Carry out failure investigation in case of product failures & resolution with implementation of CAPA. CFT/SME/Task review of deviation, change control, OOS, OOT, CAPA, Market Complaints  Conducting RCI and proposing CAPA action for failure. Effectiveness checks of implementation of CAPA.

 To Perform In-process Quality Assurance Checks (Production and Packing). To check and review of BMR & BPR. Online entries of BMR & BPR. Sample collection of all Validation Batches. Log book issues and retrievals of Production Department. SAP entries of all batches. To follows Rules of CGMP(Current Good Manufacturing Practices )