Quality Validation Officer (CSV)

Adecco; West Midlands; Hybrid; GBP 40,000 - 55,000; Full time

Job summary

A leading staffing agency in the UK is seeking a Quality Validation Officer with a strong background in compliance within the healthcare sector. This hybrid role involves leading validation activities, preparing documentation, and ensuring adherence to quality standards including GDP, ISO, and FDA regulations. The ideal candidate will possess experience with SAP and electronic quality management systems. Benefits include 25 annual leave days, competitive pension scheme, and more.

Benefits

25 days of annual leave plus 8 UK bank holidays

Competitive pension contribution

Life assurance policy paying 4 times your salary

Employee Assistance Programme

Employee Discount Scheme

Free car parking

Qualifications

• Experience in healthcare, pharmaceutical, or medical device environments.
• Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485.
• Confidence in audits and presenting validation activities.

Responsibilities

• Lead and support Computer System Validation activities.
• Prepare and review validation documentation.
• Conduct effectiveness checks and data integrity reviews.
• Assist with deviations, CAPAs, and risk assessments.
• Provide QA support and guidance to teams.
• Deliver training sessions on validation processes.
• Participate in internal and external audits.
• Support quality metrics and KPI reporting.

Skills

Experience with SAP or other enterprise systems

Documentation skills

Analytical skills

Organizational skills

Confidence in audits and inspections

Tools

SAP

Electronic QMS

Temperature monitoring systems

Job description

Quality Validation Officer (CSV)

Are you passionate about ensuring quality and compliance in the healthcare sector? Do you thrive in dynamic environments where your expertise can make a real impact? If so, we have an exciting opportunity for you to join our client as a Quality Validation Officer!

Location: Hybrid - West and East Midlands

Your Role:

As a proactive Quality Validation Officer, you'll play a crucial role in supporting computerised system validation and quality assurance activities. Working closely with the Validation Manager, you will ensure that systems – including SAP – meet the highest standards of GDP, ISO, FDA, and EU annexe 11 compliance.

Your Tasks Will Include:

• Leading and supporting Computer System Validation (CSV) activities, including planning, executing, and documenting validation and change controls.
• Preparing and reviewing test documentation, validation protocols, and change requests to guarantee that all system changes are justified, tested, approved, and compliant.
• Conducting effectiveness checks and data integrity reviews to maintain ongoing compliance.
• Assisting with deviations, CAPAs, risk assessments, change controls, and SOP creation within the Quality Management System (QMS).
• Providing QA support and guidance to operational teams, ensuring project timelines and compliance requirements are met.
• Delivering training sessions on validation and key quality processes to boost compliance awareness across teams.
• Participating in internal and external audits, supporting audit readiness, and contributing to CAPA closure.
• Supporting quality metrics and KPI reporting, ensuring timely completion of QMS actions.
• Contributing to supplier validation, including performance reviews and maintenance of validation schedules for critical equipment.

Your Profile:

To excel in this role, you should have:

• Experience with SAP or other enterprise systems, electronic QMS, and temperature monitoring systems.
• Strong documentation, analytical, and organisational skills.
• Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU annexe 11.
• Experience in healthcare, pharmaceutical, or medical device environments.
• Confidence in audits, inspections, and presenting validation activities.

Client Offers:

• 25 days of annual leave plus 8 UK bank holidays, with the option to purchase up to an additional 5 days.
• A competitive pension contribution.
• A life assurance policy that pays out 4 times your salary.
• An Employee Assistance Programme for confidential support and advice.
• An Employee Discount Scheme through Treats.
• Free car parking.

Apply Now!

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