Execute, and maintain a robust and compliant Validation Master Plans in conjunction with Validation Master Schedule and ensure effectively monitoring and adherence to the schedule
Ensure that all manufacturing equipment and critical utility systems used in the facility are fully qualified according to the Validation Master Schedule
Work closely with Production and Management to ensure Quality responsibilities and resources are aligned with business objectives
Ensure Quality Risk Management is applied to all validation activities as appropriate.
Prepare validation protocols and reports as per standard operating procedures for Qualification and Validation Documentation and other relevant associated validation procedures
Ensure the successful execution and completion of validation activities associated with equipment, process, and cleaning
Collate, review and data check results for validation reports
Ensure Out of Specification, Deviations and Incidents and non-conformance are appropriately investigated, and root cause analysis has been performed and appropriately documented
Escalate any significant quality issues and/or Out of Specification results that may impact product quality or regulatory compliance to the Head of Quality
Prepare validation protocols and reports for New Product Development activities for pilot scale batches as required
Participate in the technology transfer process of New Product Development to commercialisation with cross functional teams
Identify calibration requirements and acceptance criteria for measuring equipment. Ensure all calibration certificates comply with acceptance criteria or are appropriately investigated to ensure the facility remains in a compliant state
Prepare and review change controls as appropriate, providing justification if validation is determined to be “not required”
Liaising with both internal and external stakeholders
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