Our client, a leading biopharmaceutical company, is keen to hire a QA Validation Engineer to join their team in Sligo on a 12-month contract. Reporting to the Validation Team Leader, the QA Validation Engineer will coordinate the development and maintenance of the site validation programme and ensure site and external regulatory, quality, and compliance requirements are met.
Responsibilities of QA Validation Engineer (Full description available upon request):
- Generation/maintenance/execution of the site validation master plan.
- Generation of validation protocols and final reports to cGMP standards.
- Creation/Review/Approval of various quality documents and test data.
- Management of validation, exception event, and change control processes.
- Generation of validation investigations and implementation of corrective actions.
- Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
- Performing cross training within the team and training of new team members.
- Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Ideal Background:
- Qualification and/or degree in engineering or scientific discipline.
- Technical/Business Knowledge -Job Skills/Experience Required
- 3 years plus of knowledge of cGMP, validation and regulatory requirements relating to the biopharmaceutical industry.
- Strong communication (written and oral), presentation and troubleshooting skills required
- Effective interpersonal and organizational skills.
For a confidential discussion and more information on this QA Validation Engineer role, please contact Sarah Flynn.
sarah.flynn@collinsmcnicholas.ie
+353 719108060