Description
Roles & Responsibilities:* Participate in the development of the Master Validation Plan and strategy for specified projects.
* Take ownership of full Validation Lifecycle for specified projects ensuring adherence to defined schedules.
* Involvement in development of process risk assessment (pFMEA's).
* Creation of validation protocols (IQ, OQ, PQ) in accordance with procedures.
* Execution of validation protocols (IQ, OQ, PQ), including coordination of product builds and subsequent testing through liaising with Production, Scheduling and Quality departments.
* Compilation of test results, generation of validation reports and coordination of report approvals.
* Documentation and resolution of deviations as they occur ensuring adherence to Quality System procedures.
* Providing status updates on progress of validation activities as required.
* Assist in updating process documentation as required.
* Other related duties as assigned.
Requirements:
* Relevant third level qualification in Science or Engineering.
* Experience in process validation in the medical devise industry (3 to 5 years).
* Experience in process/equipment risk assessments using risk management tools such as pFMEA.
* Experience in generation of process validation protocols and reports (IQ, OQ, PQ).
* Able to complete work to agreed timelines.