Analyst - Quality Assurance (Computerized Systems Validation)
Onsite - Beerse, Belgium

The Opportunity

A leading global biopharmaceutical manufacturing organisation is seeking an experienced Analyst - Quality Assurance with strong expertise in Computerized Systems Validation (CSV) to support regulated manufacturing operations within an advanced therapy environment.

This role is critical in ensuring that all computerized systems remain compliant with global regulatory requirements throughout their full lifecycle - from concept and implementation through operation and retirement.

You will act as a key CSV subject matter expert, partnering closely with IT, Engineering, Manufacturing, and Quality teams to safeguard cGMP compliance.

Key Responsibilities

• Act as Process Owner for Computerized Systems Validation (CSV) for local applications

• Ensure lifecycle compliance of GxP computerized systems (concept, project, operational, retirement phases)

• Maintain and update Validation Master Plans

• Review and approve CSV documentation including SOPs, User Requirements, Risk Assessments, Validation Plans, and Test documentation

• Provide CSV and Part 11 expertise for new system implementations

• Support Change Management activities related to computerized systems

• Manage and follow up deviations arising during qualification and validation activities

• Evaluate system-related incidents and assess potential impact on product quality

• Prepare for audits and inspections and act as CSV representative during inspections

• Perform internal and supplier audits

• Provide compliance metrics and quality system reporting

• Deliver training on CSV regulatory requirements

• Monitor regulatory trends and implement continuous improvements

Essential Qualifications

• University degree or equivalent

• Fluency in English and Dutch (written and spoken)

• Proven experience within Computerized Systems Validation in a GMP-regulated environment

Essential Experience & Knowledge

• Strong knowledge of cGMP regulations including:

  • 21 CFR Part 11

  • 21 CFR 210 / 211

  • EU GMP Annex 11 and related directives

• Strong knowledge of GAMP guidelines and risk-based validation approaches

• Experience reviewing and approving CSV documentation

• Experience managing deviations and change control processes

• Experience preparing for and participating in regulatory inspections and audits

• Knowledge of software development and testing processes

• Experience in quality auditing

• Understanding of software quality metrics

Candidate Profile

We are looking for a professional who:

• Can work independently while collaborating across cross-functional teams

• Is confident acting as a CSV and Part 11 subject matter expert

• Can translate technical information across different levels of the organisation

• Demonstrates strong project management and problem-solving skills

• Understands the regulatory impact and criticality of compliance decisions

Contract Details

• Contract role

• Onsite role in Beerse, Belgium

• Start: February 2026

• Duration: Through December 2026