When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of
a team that values performance, quality and innovation. As part of a successful, growing
global organization you will be encouraged to perform at your best. With revenues of $17
billion and the largest investment in R&D in the industry, we give our people the resources
and opportunities to make significant contributions to the world.
This is a full time role in reporting and supporting the Dartford site Quality Manager.
The main purpose of the role is to ensure that product released for sale is fit for purpose, to ensure changes are introduced in a controlled fashion and in compliance with regulatory standards, to co-ordinate corrective action investigations arising from internal failures or customer complaints and to provide GMP advice to the business. The role has no budgetary responsibilities.
Key responsibilities include:
- Ensure compliance to external (regulatory) requirements, including Quality Management Systems (ISO 9001:2008, ISO 13485:2003/2012, ISO 13488 CMDCAS, Quality Systems Regulation) and the In Vitro Diagnostics Directive and that the requirements are communicated to all staff.
- Maintain compliance to the requirements of Dartford’s Quality System and ensuring the Quality Assurance team meets the QMS objectives for the site.
- Responsible for reviewing and approving quality documents in line with local quality procedures.
- Undertake QA responsibilities regarding failure investigations, hold and recall investigations, risk assessments and field actions, ensuring all necessary review are timely documented and completed.
- Perform internal audit to ensure compliance to external regulatory requirements.
- Provide metric data for Management Meetings and measurement of site quality goals.
- Provide technical and Quality support of projects, ensuring relevant data is completed.
- Participate in the audits of Remel Europe by third parties (e.g. Oxoid, Remel, BSI, FDA) and ensure corrective actions are implemented for issues arising from the audits.
- Provide support for on-going management of Master Control.
- Assist with mentoring and leading a small team of Quality Assurance professionals.
- Lead in the role of Risk Management and PMS; with knowledge of ISO14791.
- Deputise for the Quality Manager in their absence.
- Responsible for familiarising and complying with all health, safety and environmental rules, policies, procedures and any other instruction relevant to working within their area of the company.
- Any other duties/projects as are reasonable and within the skills and ability of the post-holder.
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story
to tell. Join us and contribute to our singular mission—enabling our customers to make the
world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate
on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin,
protected veteran status, disability or any other legally protected status.