Quality Validation Officer (CSV)

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! Don't miss your chance to make a difference. Take the next step in your career and join our enthusiastic team!

Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.