Quality Systems Administrator

CooperVision Limited; Southampton; On-site; GBP 32,000 - 45,000; Full time

Benefits offered by this job

Holiday entitlement

Pension scheme

Healthcare cover

Life assurance

Wellness platform

Job summary

CooperVision Limited is seeking a Quality Systems Administrator to join the UK R&D QA team at The Vision Centre, Southampton. The role focuses on supporting the UK R&D QMS and global initiatives within R&D QA.

You will monitor and improve all areas of the Quality System, including document control, batch record reviews, CAPA/NCR investigations, and audits. On-site work required in Southampton with travel if needed.

Qualifications

• Experience with quality systems in medical device manufacturing.
• Experience in quality assurance teams.
• Auditing experience desirable.

Responsibilities

• Manage Document Change Control Process and Simple Approvals, review DCOs and APPs, create document numbers.
• Review and approve Batch Records to ensure GMP/GDP compliance.
• Support CAPA and NCR investigations and close actions with root cause reviews.
• Support CAPA investigations, implementing and reviewing effectiveness.
• Support projects in Concept Feasibility, Design Control and Risk Management activities.
• Assist audits (ISO 13485, FDA 21 CFR 820) and supplier audits; communicate findings and close out actions.

Skills

Quality systems

Quality Assurance

Documentation

Communication skills

Organisational skills

IT skills

Relational databases

Education

Bachelor's degree in a relevant field

Tools

Word

Excel

Outlook

Relational databases

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 improvethe way people see each day. It’s more than makingcontact lenses, it’s about giving lens wearers freedom andconfidence 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 teammonitoring 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 <5%/year (3 weeks per year).

A full job description is available upon request.

About you:

We are looking for someone with:

Knowledge, Skills and Abilities:

• Working knowledge of quality systems, processes, and their interactions in a medical device manufacturing environment.
• Excellent written and verbal communication skills.
• Excellent organisational skills.
• Computer literate, with intermediate skills in the use of Word, Excel and Outlook, and some knowledge of relational database systems.
• Ability to read and understand technical material.
• Ability to work effectively either alone or as part of a team.
• Ability to prioritise workload as appropriate.
• Must be detail oriented
• Ability to work in a challenging and fast-paced work environment

Experience & Education:

Experience in:

• Quality systems experience working in a Medical Device Manufacturing or related environment
• Experience of working in Quality Assurance teams.
• Auditing experience (desirable).

Education:

• Educated to Batchelor Degree level preferable or with suitable relevant quality experience / qualifications.

What we offer:

You’ll receive competitive compensation and a fantastic benefits package including holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!

We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.

We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision.

What you can expect:

As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.

All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.