The QA Validation Specialist is responsible for oversight of validation activities 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. Some key tasks and responsibilities are outlined below:
- Provide expertise in the area of validation at Takeda Ireland Limited, Grange Castle (TILGC), 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 TILGC change controls are assessed for impact on validation.
- Review and Approval of TILGC validation master plans.
- Review of deviations and non-conformances associated with validation activities.
- Review and provide input into the TILGC periodic review and revalidation programme.
- Participate in cross-functional project teams as the quality assurance validation representative.
- Participate in TILGC Continuous Improvement programmes.
- Participate in other projects as directed by the Quality Systems & Compliance Manager.
- 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 Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL 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.
- Primary degree is scientific discipline.
- A minimum of 5 years working within quality in the pharmaceutical industry.
- Excellent verbal and written communication skills
Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.