QA Administrator Apprentice - East Grinstead, United Kingdom - Thermo Fisher Scientific
Description
Position Summary:
Our MBD East Grinstead facility is at the forefront of our quest to keep Antibiotics effective and relevant for today's results-oriented environments.
The East Grinstead site is the only manufacturer of the Sensititre range of AST products, critical in the fight against primary infections and Covid 19 secondary infections.
These vital products enable healthcare professionals to make an accurate diagnosis and to prescribe the right amount of the required antibiotic.
Working with our East Grinstead Sensititre products, our customers save lives every day and we help them to make the world healthier, cleaner and safer.
Playing a key role in our Site Mission is the Quality Assurance team, who ensure that all medical devices manufactured on site are compliant to the Quality Management System as per ISO 13485:2016.
This is a huge opportunity to learn from the best, develop as a quality profession al and fulfill your true potential.
Working within this team you will ensure product release and documentation for the QMS is maintained as part of document control and control of records.
The position requires a proficient communication and IT skills to support the site on the day to day administration of key quality tasks such as batch release and new product approvalsResponsibilities:
- Ensure that general day to day activities such as batch release, review/approval of nonconformances, and deviations are completed within the expected timelines
- Assist in the audits (pre audit and post audit follow up) to external (regulatory) requirements, (ISO 13482:2016, MDSAP and the In Vitro Diagnostics Regulations).
- Responsible for reviewing and approving SOPs in line with change process.
- Monitor supplier reviews and performance and update the QMS accordingly
- Add, monitor and flag overdue non conformances to the Quality Manager and department
- Assist in metric data for the Quality department.
- Ensure the daily Tier board information is update and tracked
- Any other duties/projects as are reasonable and within the skills and ability of the postholder.
Minimum Requirements/Qualifications:
- High attention to detail
- Ability to communicate openly
- Work flexibly to ensure deadlines are met
- Competent in the use of the MS Office suite
- Usage of SAP or related system
- Experience in cGMP or GMP environment
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