My client a leading Pharmaceutical company now require a QA Validation Specialist to join their expanding team.
The QA Validation Specialist 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
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Engineering Technician
- 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.
- Review of deviations and non-conformances associated with validation activities.
- Review and provide input into the periodic review and revalidation programme.
- Participate in cross-functional project teams as the quality assurance validation representative.
- Participate in 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.
Requirements of QA Validation Specialist:
- Primary degree is scientific discipline.
- A minimum of 5 years working within quality in the pharmaceutical industry.
- Excellent verbal and written communication skills