Officer/ Sr. Officer - Quality Assurance

Role & responsibilities

• To coordinate with cross functional department for execution of training planners and maintain training record for same.
• To master, issue and retrieve of SOPs/BMR/BPR/QC dockets and other documents in-line with the laid down procedure.
• To maintain vendor related documents and conduct vendor audits.
• To investigate and prepare Market Complaint investigation report.
• To take follow up and communicate with customer/vendor regarding Complaint.
• To handle Change control/Deviations/Incidents/NCR/CAPA.
• Review of quality technical agreements
• Responsible to maintain annual validation/qualification planner.
• Responsible to day to day qualification/validation activity planning, execution and tracking.
• Responsible to any qualification trigged through quality management system.
• Accountable for area qualification, LAF qualification, utility qualification and operation of NVPC.
• Participate in Aseptic process simulation, cleaning validation, thermal mapping of area as well as equipments.
• Operation of Data logger.
• Responsible for provide uncontrolled documents as per requirement.
• To assist the Head of Department for preparation of regulatory inspection.
• To Participate in Change control\Deviation\Incident investigation.
• Execution of qualification/validation activity, compilation of report & Maintance of protocol.
• Responsible to report deviation and incident.
• Responsible to implementation of CAPA.
• Participate in investigation and compilation of the related documents. Responsible to audit preparation, execution and compliance (internal as well as external audit).
• Responsible for co- orientation with internal department personnel as well as external vendor.