Manager - QC - Compliance

Role & responsibilities

• Planning and execution of activity with respect to IP/FP & Raw material section.
• Investigation of OOS/OOT/LIR/Extraneous peaks.
• Review of investigation reports of OOS/OOT/LIR/Extraneous peaks and closure of investigations.
• Training Management System and training to all Quality Control.
• Exposure to SAP (Systems, Applications & Products in Data Processing) and LIMS (Laboratory information Management System).
• Co-ordinatation with team member during internal and external audits.
• Co-ordinatation with cross functional departments for execution of laboratory related activities i.e. material receipt, testing plan and releases as per timeline.
• Co-ordinatation with Instruments/Equipment vendor or suppliers.
• Handling of Change Controls, CAPA (correction and preventive action), Deviations, Market Complaints, Risk Assessment wherever applicable.
• Responsible to review SOP (Standard operating procedure), IOCP (Instrument operating and calibration procedure), GTP (General test procedure), Protocols, Reports, Training Modules, Analysis report, Record of Analysis etc. in DCS/Documentum wherever applicable.
• Co-ordinatation with regulatory to fulfil filing requirements with respect to OSD (Oral solid dosage) and Oncology Injectable.