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Strategic and planning
Functional
Core
- Prepare Validation master plan annually and ensure adherence to schedule for qualification and validation of equipment / instrument / area etc.
- Prepare and get the protocol reviewed and approved prior to execution of the Validation activity.
- Participate in validation and qualification as per the approved protocol.
- Work with the user department in listing down the observations as per the approved and executed protocol.
- The conclusion drawn from the Validation / Qualification to be shared with the QA / Quality Head.
- Working with the Engineering Team / Calibration team with compliance with SAP.
- Support the DMS system implementation across the plant.
Internal process
- Adherence to schedule for validation and qualification
- Qualifications (IQ/OQ/PQ) of all new machines / Equipment.
- Validation of the process to be carried out as per the stipulated frequency.
Authorities
- Authorised for final release of finished product batches
- To raise and approve QMS documents like change control, deviation, OOS, Investigation, etc.
- To authorize print request of documents in Document Management System (DMS)
- Authorized to publish SOP. Formats in DMS
People development
Training to Management associates (MA) on details of Validation and Qualification
Training to Plant associates (PA) on the Basis concept of Validation and Qualification.
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