Process validation engineer
Process validation engineer
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Job Description
Job Title: Process validation engineer Medicals
Years of Experience: 58 Years
Locations: Aurangabad
Target Domain Medical Only
Key words to search IQOQPQ (Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ))
Review the changes requested by Supplier for process changes Equipment changes line transfer material sourcing change
Define the PPAP requirements and other site specific requirement for the change
Prepare draft PPAP and Coordinate with supplier for the evidence and regulatory/FDA requirements
Review various PPAP documents received from supplier (PFD PFMEA PCP Validation documents Process capability study reports etc) and validate against the process or part requirements
Review process validation plans protocols and reports associated with Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ).
Coordinate with internal stakeholders/SMEs to obtain approval and route it to respective stakeholders.
Work with Sterility assessment bio burden SMEs to close as per site requirement based on type of change
Coordinate with Change analyst to close the ECN/ECRs after appropriate approval
Communicate SICR owners & Site SPOC on the status of each SICRs and ETA
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Employment Type
Full Time
