About this role
Quality Systems Administrator
Southampton, Hampshire, United Kingdom
On-site
Be the First to Apply
Job Description
Job title: Quality Systems Administrator
Department: New Product Development
Location: The Vision Centre, Adanac Park, Southampton
GLS: P01
Working hours: Full Time, Monday-Friday, 0830-1630. On site 5 days per week.
A brighter future awaits you
CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.
Job summary – What to expect:
The Quality Systems Administrator will be based in UK R&D site (The Vison Centre – Nursling) as part of the UK R&D QA team and will be reporting to the Principal R&D Quality Systems Manager. This position focuses on supporting the UK R&D QMS and any CooperVision global initiatives in which R&D QA is involved in.
In this role you will work as part of a team monitoring and improving all areas of the Company’s Quality System including supporting and promoting quality assurance and compliance activities.
-
Responsible for the Document Change Control Process and Simple Approvals including conducting Quality review of DCOs, APPs and creation of document numbers within the Quality System.
-
Responsible for the review and approval of the Batch Records to ensure compliance with GMP / GDP requirements.
-
Supports the CAPA and NCR investigation to ensure timely and effective closure in line with the quality objective metrics and assists in reviewing root cause investigations.
-
Supports Investigation, Implementation and Effectiveness Review activities for CAPAs, working with CAPA Leaders and other RA/QA team members ensuring a consistent approach.
-
Supports projects as part of Concept Feasibility, Design Control and Risk Management (such as filing, ETR training verifications and timeline DRB deliverables, document change control, annual risk management reviews, etc.)
-
Support Internal, External (ISO 13485 and FDA 21 CFR part 820 inspections) and Supplier audits when requested leading and participating in the audits, communicating findings to appropriate personnel, and working to ensuring the timely close out of actions derived from internal audit findings.
Travel Requirements:
Travel to other CooperVision sites or suppliers in support of site quality objectives and processes. Travel time