Duration:
15 Months Contract
Location:
Galway
Non Negotiables:
1. 1-2 years experience in a similar role
2. Level 8 University degree in a related discipline
3. Medical Device industry experience required
4. Based in Galway so must be willing to be onsite as required
5. Sponsorship not possible, MUST HAVE a valid work permit for Ireland that allows you to work uninterrupted for 15 months.
Responsibilities may include the following and other duties may be assigned
* Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose Audit activity, Cycle Requalification, Supplier Change control etc
* Support sterility assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites
* Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation
* Support cross functional teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards
* Collaborates with engineering and manufacturing functions to ensure quality standards are in place
* Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
* Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
* Performs calculations, data integrity checks, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements
* Adhere to all relevant site wide procedures and practices for Safety & GMP
Required Knowledge and Experience:
Requires broad theoretical job knowledge typically obtained through advanced education. Requires a University Degree and 1-2 years of experience.