QA Validation Specialist
Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?
Do you want to make a difference?
If the answer is ‘yes’ then you’re just the kind of person we’re looking for!
We have a new opportunity for a Validation Speciialist. The successful candidate will be involved in:
- Ensuring that the company validation documentation meets applicable ISO and FDA Quality System Regulations. The post holder is expected to maintain an area of specialist knowledge and to take responsibility for the provision of resources in this area.
- Contributing to the development of policies and procedures within their area of specialism and ensuring that these are implemented and compliant with the quality system.
- Reporting the status of their area of responsibility to senior managers as required.
- Co-ordinating workload and set objectives for staff member(s) assigned to assisting with their area of specialism to ensure that the operational objectives of the department are met and delivered within agreed timelines.
- Ensuring quality within validation activities across the company. To evaluate validation activities across the company and suggest improvement initiatives to ensure that departments are performing validation as efficiently as possible.
- Responsible for understanding their key areas of responsibility and ensuring that they are understood and followed throughout the company.
- Participating in external audits as required.
Essential:
- A good, relevant scientific degree (or equivalent) or Quality Assurance/manufacturing engineering background
- Previous experience of working in a quality system environment, preferably within medical devices or similar.
- Extensive knowledge of validation within a medical device or similar environment
- Working knowledge of ISO13485 and 21 CFR Part 11 and Part 820 quality systems
- Excellent organisational skills
- Excellent communication skill, both verbal and written
- Excellent leadership skills
- Good analytical skills
- Good working knowledge of Microsoft Office
- The ability to manage time efficiently
- Must be able to work and lead in a team environment
- The ability to work autonomously
- To be confident and enthusiastic approach to work
- To be flexible to the needs of the business
Rewards & Benefits:
Competitive Salary
Contributory Pension, 6% company contribution
Annual Bonus scheme
25 days annual plus bank holiday and service days
Life cover 3 x salary
Medicash Healthcare Plan, this includes routine dental treatment, opticians, prescription charges,
Sustainable Electric Car Scheme
Cycle to work scheme, up to £2500
Travel wise, travel assistance scheme
Working for us:
Founded in 1986 by a group of former researchers based at the University of Birmingham, Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency. Our position as a scientific leader in our field for Multiple Myeloma provides solutions to clinicians and laboratories around the world.
Integral to the success of Binding Site, is the way we value, develop, and empower our workforce. Everyone is welcome irrespective of race, gender, ethnicity, sexuality, religion, age or disability. We pride ourselves on been an inclusive employer for all, reinforced by been Business Disability Forum Member , Stonewall Champion & LGBQT+ foundation.
There’s lots of opportunities to get involved with our Charity Committee, EDI or Employee forums in creating a collaborative culture by winning together and making a difference every day
We recognise that work plays a big part in our lives, so we are proud of our positive employee engagement record, our and our commitment to continue listening to our people and improving what we do. We firmly believe that by working together we can make the Binding Site the best possible place to work and build a sustainable future for our workforce and local communities.
In addition, Binding Site has been recognised at the 2021 Birmingham Post Business Awards, winning both “Company of the Year” and “International Trade and Export” Awards.
We aim to make reasonable adjustments and adaptions to ensure our recruitment process is inclusive to all. Please get in touch directly if there is specific support required