QA -Equipment Qualification / Validation

Role & responsibilities

To review classification of equipment as per type of PLC.

To review critical and non critical alarm list of equipment.

To assist in investigations and impact assessment for the events/incidents observed in the procedure in

consultation with designee.

To review the "Record for Alarm Acknowledgement during Operation".

To review the protocol and report of qualification.

To verify and evaluate the requirements as per GXP.

To perform validation activities as per the responsibilities defined in the CSVMP

To review the Computer System Validation Protocol & Report.

To review and audit the computer systems.

To review the URS, Risk Assessment, Test Protocols and Validation Summary Reports.

To evaluate the need for revalidation and requalification of component for function impacted by SRR.

To review the relevant document for completeness and correctness.

To verify the equipment against check points & equipment qualification availabilities against URS

Preferred candidate profile

Experience 3 - 10 Yrs

Qualification - BE In Electronics and Telecommunication