Job Description
Perform characterization studies and DOE’s (as required).
- Develop validation strategies
- Write/Submit/Execute IQ (Installation Qualification) /OQ (Operational Qualification) /PQ (Performance Qualification) and TMV (Test Method Validation) protocols and submit to the document management system for approval.
- Procure the required materials for validations (if required).
- Coordinate the execution of validations with operations.
- Software validation (as required).
- Closeout validation activities.
- Write Test Reports and submit in the applicable Quality Documentation Management System for approval.
- Provide technical support and engineering troubleshooting as required to Operations.
- Write or modify the following documents: PFD, PI, MOP, EPR, and CAL (as required).
- Evaluate new Equipment as required.
- Support on CAPA (Corrective Action / Preventive Action) /NCR (Non-Conforming Request) / NCC (Non-Conforming Corrections) action item activities to...
- Develop validation strategies
- Write/Submit/Execute IQ (Installation Qualification) /OQ (Operational Qualification) /PQ (Performance Qualification) and TMV (Test Method Validation) protocols and submit to the document management system for approval.
- Procure the required materials for validations (if required).
- Coordinate the execution of validations with operations.
- Software validation (as required).
- Closeout validation activities.
- Write Test Reports and submit in the applicable Quality Documentation Management System for approval.
- Provide technical support and engineering troubleshooting as required to Operations.
- Write or modify the following documents: PFD, PI, MOP, EPR, and CAL (as required).
- Evaluate new Equipment as required.
- Support on CAPA (Corrective Action / Preventive Action) /NCR (Non-Conforming Request) / NCC (Non-Conforming Corrections) action item activities to...
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