About this role
- To Prepare, Review and Execution of Validation / Qualification Protocols and Reports in co-ordination with respective departments.
- To review and monitor Preventive Maintenance activity of equipment’s / instrument / utility.
- To review and monitor Calibration of instruments, schedule Validation, Periodic Performance Qualification Review, etc. are carried out as per the approved schedule.
- To assist in preparation of Validation Master Plan.
- To execute the Process Validation Protocol, Cleaning Validation Protocol and Hold time study protocol.
- To Prepare Annual Product Quality Review.
- Development, periodic review, revision and implementation of Standard Operating Procedures (SOPs) as required.
- To assist in investigation of Deviation, Market Complaint, Out of Calibration, Out of Trend(OOT) and Quality Risk Management etc.
- To perform Self-Inspection activity.
- Sharing required documents and data required by cross functional team and MA holder based on requirement.
- To implement new SOPs based on findings during self-review or during any customer or regulatory audits.
- Imparting training for new and existing SOPs based on the schedule frequency.
- Responsible to carry out all the activity in compliance with cGMP, regulatory and company EHS policy.