QA CSV Specialist

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
• Personal growth support with tailored training and clear career development
• A stable environment where your technical skills directly contribute to improved patient care
• The chance to work with high tech diagnostic systems at top tier healthcare institutions
• A warm and collaborative culture focused on trust, ownership and long term impact

We are looking for an experienced QA CSV Specialist to provide independent quality oversight and practical validation support for computerised systems in a regulated manufacturing environment.

In this role, you will support our client in maintaining the validated state of manufacturing execution systems, industrial automation platforms, monitoring solutions and supporting IT infrastructure. You will collaborate with technical experts, system owners and business stakeholders to ensure that validation activities, system changes and lifecycle decisions meet regulatory expectations. Your focus will be on applying a pragmatic, risk based approach to computerised system validation, safeguarding data integrity and ensuring inspection readiness throughout the system lifecycle.

Key responsibilities

You will take ownership of quality oversight and validation support activities across a range of GxP computerised systems.

• CSV Lifecycle Oversight: Provide independent quality support throughout system implementation, validation, operation, change management, periodic review and retirement.
• Validation Documentation: Review and approve validation plans, impact assessments, requirements, risk assessments, specifications, test documentation, traceability matrices and summary reports.
• Quality Risk Management: Evaluate system changes, incidents, deviations, defects and CAPAs for their impact on product quality, patient safety, data integrity and the validated state.
• Risk Based Validation: Apply a pragmatic validation approach focused on critical system functions, electronic records, interfaces and compliance controls.
• Data Integrity Compliance: Assess access management, audit trails, electronic records, electronic signatures, time synchronisation, backup, restore, retention and data transfer controls.
• System Architecture and Data Flows: Support data flow mapping and assess system boundaries, interfaces, critical records, metadata and control ownership.
• Automation and Infrastructure Oversight: Provide QA support for industrial automation systems, environmental monitoring solutions, network infrastructure and associated IT services.
• Inspection Readiness: Support periodic reviews, regulatory inspections, internal audits and the preparation of compliant validation documentation.
• Stakeholder Collaboration: Work closely with engineering, automation, IT, quality and business stakeholders to resolve compliance challenges and maintain clear accountability.
• Quality Decision Making: Communicate quality risks, challenge validation approaches constructively and elevate significant compliance concerns when necessary.

Required competences & skills

• Educational Background: Bachelor’s or Master’s degree in Engineering, Automation, Computer Science, Life Sciences or a comparable technical or scientific discipline.
• Relevant Experience: Typically 4 to 7 years of experience in computerised system validation, quality assurance, automation or computerised systems within a GxP regulated environment.
• CSV and Validation Expertise: Practical experience with validation lifecycle documentation, testing, change control, deviation management and maintaining the validated state.
• Regulatory Knowledge: Good working knowledge of CSV, SDLC, EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5 and recognised data integrity expectations, including PIC/S guidance.
• Data Integrity and Risk Management: Strong understanding of risk based validation, electronic records, electronic signatures, access controls, audit trails, backup and restore, interfaces and supplier documentation.
• Technical Understanding: Ability to interpret technical system architectures and translate complex system dependencies into clear validation strategies and quality decisions.
• Communication and Collaboration: Strong organisational and communication skills, with the con