Applications are invited for the permanent role of Validation Executive at Takeda Ireland Limited (Grange Castle)
The position reports into the site Quality Director and the key responsibilities for the positions are:
- Co-ordination of site validation activities including:
- Qualification of equipment and utilities
- Computer system qualification
- Process validation
- Cleaning validation.
- Ensuring compliance with current industry regulations and guidelines relating to validation.
- Preparation of validation policies and SOPs.
- Preparation and review of TILGC validation master plans, protocols and reports.
- Execution of validation protocols, including preparation of, and review of, deviations.
- Participation in cross functional project teams as the validation representative.
- Co-ordination of the TILGC periodic review and revalidation programme.
- Review of all TILGC change controls assessing impact on validation.
The successful candidate will have:
- A degree in a Science or Engineering discipline
- At least 5 years experience working in a validation role in a regulated environment
- API processing experience is highly desirable
- Excellent knowledge of validation regulations and guidelines
- A strong technical understanding of processes, equipment and computer systems
- Excellent written and verbal communication skills
Applications for this position must include an up to date CV and should be submitted via the Employment Opportunities Page on the Company Website www.takeda.ie on or before 30th November 2012. Please do not submit hard copy CV’s as unfortunately they will not be accepted.
Takeda Ireland Limited is an Equal Opportunities Employer