Job Summary

Assure that all products manufactured at OEM are designed, manufactured and released according to established procedures and validated processes. Assure that all facilities, utilities and equipment involved in the production of all products manufactured at OEM complies with defined standards.

Assure the proper implementation of good quality practices in all processes at OEM and be able to identify improvement opportunities necessary to contribute to the robustness of the OEM Quality System.

Key Accountabilities
Review and approval of manufacturing procedures, general procedures or instructions.
Change Management: evaluate the impact of the proposed changes, approve action plan proposal and its implementation.
Validation/ Qualification:
Review of qualifications for facilities, equipment and utilities, including qualification strategy, execution and management of potential deviations detected.
Factory acceptance Test (FAT) / Site acceptance test (SAT) execution / approval.
Review of process validations, including validation strategy,



execution and management of potential deviations detected.
Be able to establish a strategy to validate changes. Review validation strategies and the corresponding documentation (protocol and report)
Risk Assessment:
Carry out, review and approve the risk assessment performed at OEM to evaluate the impact of changes in the final product.
Provide training in validation & risk management to OEM staff to ensure that the organisation is both skilled in implementation and is utilising best in class methodologies.
Participate in Internal and External Audits as needed.
Perform Quality Training to all personnel at OEM.
Management of Non-conformances and CAPA.
Ensure that validation lots are appropriately tested, reviewed and released.
Implement new procedures and instructions as a result of the observed practices on site to contribute to the Quality System robustness.
Be proactive regarding the continuous improvement in Quality proc

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