Analyst - Quality Assurance
Solliciteren
Plaats
Beerse2340
Antwerpen
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-02-20Online to:
2026-04-21EUR 20.00 HOUR
Analyst - Quality Assurance
- SEC Life Sciences
- Antwerpen
- 2 dagen geleden
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
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