Sector: Life Sciences
Consultant: Harvey Havell
Salary: £26000 - £32000
Job Status: Contract / Full Time
Location: London, NW2
Role: FTC 12 – 14 months (Maternity Cover)
Hours: Monday – Friday ; 9am – 6pm.
Start date: October 18
The Company was founded in the early 2000s and recognised as a leading UK supplier and manufacturer of medical supplies and care products supplying over 10,000 products and manufacturing 700+.
Title: QA/QC/RA Supervisor
- To ensure that the company’s manufacturing and distribution operations are fully compliant with all relevant Medical Device Regulations as well as taking an active part in audits, both internal and external.
- To ensure new NPD programmes are project managed to deliver to agreed date.
- Maintaining governing policies, operating procedures and work instructions. Address any gaps as discovered to the Quality Director.
- Issue and control documented procedures and close monitoring of procedure effectiveness.
- Initiate corrective actions to prevent the occurrence of any product non-conformities before and after delivery.
- Implementation of Quality Management System with respect to ISO 13485 & Directive 93/42/EEC and relevant amendments. Knowledge and gradual implementation of MDR 2017/745.
- Verify label and labelling as per ISO 15223-1 and 21 CFR 801.
- Maintenance and control of Technical Files in accordance with Directive 93/42/EEC (Amended by 2007/47/EC).
- Work with cross-functional teams (internal and external)and critical suppliers to :
- ensure that quality of product and services are achieved, improved and maintained in conjunction with functional audits and regulatory compliance.
- resolve product quality identified through complaints and/or NC/CAPA processes.
- Ensure awareness of essential regulatory requirements throughout the company.
- Provide accurate and timely reporting to quality director to assist planning and management of operations and communicate an appropriate compliance strategy to support implementation of MDR and ISO requirements.
- Inspection, management and monitoring of samples / incoming goods (post production).
- Management of supplier evaluation / approval processes, maintenance of approved supplier list, monitor their on-going performance.
- Review of and contribution to contractual agreements and specifications with suppliers.
- Accountable for internal and external audits, reporting and liaising with notified body and competent authority.
- Report on performance of the management system, including the need for improvement at the Management Review meeting.
- Liaison with suppliers ensuring their operational compliance with the company`s policies such as Labour Standard Assurance System. Responsible for LSAS target level achievement; audited by third party.
- Contribution to business development by assisting in regulatory compliance of new products as such a revenue target is achieved.
- Work on new product development, sample review and product evaluation.
- Work with external consultant to ensure the company is fully compliant with a range of UK and European Regulations and ensuring that the company`s policies always reflect such updates.
- Keep accurate and up-to-date record as such the documents are legible, traceable and retainable.
- Other duties as assigned by Senior Management.
Preferred but not essential:
- Knowledge and/or experience of GDP in accordance with regulation 18 of the Human Medicines Regulations 2012 (SI 2012/1916)
- Knowledge and/or experience of FDA regulation.
The successful candidate:
- Life Science Graduate with at least 3 years’ hands on experience in medical devices or pharmaceutical company or, HND/Diploma level with minimum of 5 years’ hands on experience in the same field.
- Outstanding supervisory experience.
- Excellent written and verbal English skills.
- Numerate with excellent attention to detail.
- Good data input skills.
- Competent IT capabilities (Excel and Word) and Outlook.
Personal skills :
- Ability to direct and actively working to attain and ensure highest level of internal and external compliance and legal requirements.
- Excellente communication and service skills as role requires regular contact with internal teams, suppliers, clients, subcontractors and dealing with queries and resolving issues.
- Self-motivated, flexible, able to multi-task, good organisational and time management skills, ability to prioritise and manage workloads.
- Ability to work confidently, remain calm under pressure, meet deadlines and work in a team environment.
- Demonstration of positive team player spirit and cooperative sales skills.
If this is of interest, please click the apply now button.