Sector: Life Sciences
Consultant: George Owen
Salary: £26000 - £26000
Job Status: Permanent / Full Time
Seven Life Sciences is looking for a QA/QC Regulatory and Compliance Executive to work for a UK-Leading medical supplies company. Our client specialises in the manufacturing and distribution of medical supplies to GP’s, Clinics and Hospitals across the nation. The role is based in London.
As a QA/QC Regulatory and Compliance Executive, you will be on hand to support and work in the QA / QC Team and alongside the COO and the Head of Quality Assurance to ensure that the company’s manufacturing and distribution operations are fully compliant with all relevant Medical Device Regulations for medical devices; as well as taking an active part in audits, both internal and external. You will also work in the QA/QC Team for new product development/projects and maintain existing products; with reference to applicable standards and regulations.
- Work on new product development, sample review, product evaluation and prepare technical documents.
- Create, update and maintain technical files for medical devices.
- Prepare technical specification, datasheets and conformity certificate. Reporting and reviewing non-conforming products.
- Keep accurate and up-to-date record as such the documents are legible, traceable and retainable.
- Liaise with suppliers in relation to ensuring their operations are fully compliant with the company`s policies and relevant medical device regulations.
- Address/resolve CAPA, goods inspection, traceability and system records.
- Work with external consultant to ensure the company is informed of new regulation and ensure that the company`s policies always reflect such updates.
- Deal with faulty product, customer complaint and management of process.
- Communicate/vigilance reporting to notified body and competent authority in relation to medical device matters.
- Manage the supplier evaluation and approval processes, maintenance of approved supplier list, monitor their on-going performance.
- Verify labels as per 15223-1 and 21 CFR 801.
- Participate in internal and external audits.
- Quality assurance of sterile and non-sterile medical devices.
- Ensure we are compliant with Labour Standards Assurance System (LSAS) audit.
- Other duties as assigned by senior managements and head of the QC department.
Qualifications: Ideally a graduate, but minimum education to A-Level standard and above.
Experience: Experience within a pharma or medical devices manufacturing company. Outstanding supervisory experience. Knowledge and/or experience of FDA regulation is desirable.
Compliance: Excellent written and verbal English skills. Numerate with excellent attention to detail. Good data input skills. Competent IT capabilities (Excel and Word) and Outlook.
Travel: The ability to commute to and from work independently is essential.
Hours: 37.5 hours p/w. Mon-Fri 9am-5pm.
- Pension Scheme.
- Onsite Parking.
- Excellent working environment/brand new offices.
- Accessible and supportive management.
Working with Seven Life Sciences:
Seven Life Sciences is a leading provider of staff to pharmaceutical, medical device, biotech and clinical companies across the UK.
Seven is the recruitment service that guarantees experienced, qualified and available staff exactly when you need them. Our expert talent acquisition team seamlessly connect professionals to all areas of life sciences; including Pharma, Quality Assurance, Regulations, Compliance, Sales, Clinical, Operations, Research and everything inbetween.
After being shortlisted for multiple awards in 2018, we are proud of our nationwide reputation for providing a world-class recruitment service that is underpinned by honesty, integrity and attention to detail.
Refer a friend, family member or colleague for £250
If you’re not the perfect match for this role, but you know someone who is, help them find their next role by referring them to Seven Life Sciences. As a little ‘thank you’ from us, you will receive £250 for every referral that is successfully placed into a new role.