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 controlDeviationIncident 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.