The QA Specialist is a Fixed Term Contract (FTC) position to support a new Oncology API product introduction project on a site with a well-known Biotechnology company based in Grange Castle. The QA Specialist is responsible for the coordination of validation activities on site ensuring compliance with current regulatory requirements. The QA Specialist will have specific and varying duties as assigned by the Head of Quality Assurance. The role will primarily liaise and support the Small Molecule Manufacturing facilities.
- Provide expertise in the area of validation at the client’s Grange Castle site , 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:
- Laboratory equipment validation.
- Process validation.
- Cleaning validation.
- Qualification of premises, equipment and utilities.
- Computer system qualification.
- 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.
- Review of deviations and non-conformances associated with validation activities.
- Execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities.
- Review and provide input into the periodic review and revalidation programme.
- Participate in cross-functional project teams as the validation representative.
- Support QA Operational activities as required.
- Participate in Continuous Improvement programmes.
- Participate in other projects as directed by the Head of Quality Assurance
- Flexibility is important and responsibilities may change or other duties may arise for this position.
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of the client within the workplace.
- Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
- Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
- Minimum of a BSc Degree (life science).
- A minimum of 5 years working within quality in the pharmaceutical industry.
- Validation experience preferable.