BBI Solutions has served the global diagnostics industry for over 50 years, as a leading developer and manufacturer of raw materials and finished test platforms for the in-vitro diagnostics market. Product ranges include antigens, antibodies, enzymes, serums and plasma’s as well as renowned labels for lateral flow and ELISA assays.
Our mission is to deliver exceptional products and technologies that people rely on to enjoy a better quality of life. Through innovation, partnership, effective delivery and the collaboration of our people, we constantly strive to help set industry standards, engender trust and build our reputation for excellence.
We currently have an exciting opportunity for a Document Controller to join our Transfer Team on a fixed-term basis at our Crumlin site.
The salary offered for this role is competitive and makes up part of BBI’s attractive benefits package, which includes:
5% contributory pension scheme
Private health care scheme
Generous annual leave package totalling 32 days (inclusive of bank holidays)
Cycle to work scheme
As a Document Controller you will be responsible for the implementation and maintenance of documentation and for general quality system requirements for the Transfer department. You will be responsible for the implementation of technical, project and procedural documentation within the department alongside supporting the department and wider site with quality and compliance activities in support of BBI’s quality system.
Key responsibilities will include but not be limited to;
Transfer department design document control
Liaison with technical teams to create, update and approve required production, quality control and associated supporting documentation
Production and maintenance of department procedures and training modules
Planning and tracking product documentation through later stages of BBI’s development process, through transfer and into routine manufacture
Responsible for Transfer department compliance to BBI’s quality system
Control and maintenance of Transfer compliance activities including any deviations and non-conformances plus liaison with the quality department to drive CAPA activities
Supports the site QMS in accordance with ISO 13485, cGMPs (21CFR 820), Global Quality System procedures where required
Supports the customer audit process
Maintains positive relationships with Site functions
Ensures site and customer requests; general queries, requests for documentation and completion of questionnaires are completed in a timely manner for the scope of the department
Collating relevant reports as required for the business reviews
Leads and participates in Continuous Improvement projects
This role would be best suited to somebody who is outcome driven with a continuous improvement mindset. To be successful in your application you will need to demonstrate an ability to translate technical details into procedural instructions for routine manufacture. Experience of working to cGMP or medical device/pharmaceutical industry experience is highly desirable.
If you are an internal employee applying for this vacancy you and your manager are required to complete an internal transfer form. This needs to be completed in full and attached to your application along with your CV and cover letter.
Crumlin, South Wales