Timely execution of the Validation Master Plan (VMP).
Preparation and execution of all protocols related to qualification and validation.
Timely execution of Qualification of all current machine / Instrument / equipment.
Monthly details status report
Primary responsibilities
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.
Key Result Areas
Proper planning before starting Qualification and Validation activities.
Involvement of the cross functional team.
Real time data entry
Study to be carried out only after Pre-Approval has been approved.
Status report on a monthly basis.