Description:
Duties of the role/Responsibilities
- 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
Education/Experience
- University Degree in a relevant technical discipline (e.g. Engineering, Science)
- 1-2 years’ experience in a medical devices or related environment
- Requires broad theoretical job knowledge typically obtained through advanced education.