QA Validation Specialist
The QA Validation Specialist is responsible for the coordination of validation activities for the Cell Therapy facility on site ensuring compliance with current regulatory requirements. The QA Validation Specialist will have specific and varying duties as assigned by the Quality Systems & Compliance Manager. The role will primarily liaise and support the Cell Therapy Manufacturing facility.
- The QA Validation Specialist will provide expertise in the area of validation, ensuring compliance with current industry regulations, guidelines and trends.
- Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Including but not limited to:
- Qualification of premises, equipment and utilities.
- Computer system qualification.
- Laboratory equipment validation.
- Process validation.
- Cleaning validation.
- Prepare and maintain policies and SOPs associated with validation.
- Ensure that all change controls are assessed for impact on validation.
- Review and Approval of validation master plans.
- The QA Validation will execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities.
- Participate in cross-functional project teams as the validation representative.
- Participate in other projects as directed by the Quality Systems & Compliance Manager.
The next QA Validation Specialist should have a primary degree is scientific discipline with 3 years’ experience working within quality in the pharmaceutical industry. You should demonstrate excellent communication skills with
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