Quality Systems Analyst

Randstad; Oost-Vlaanderen; Hybride; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

13th month salary

Double holiday pay

Hospitalization insurance from day 1

Group insurance (pension savings)

Flex Income Plan

4 weeks statutory holiday + 12 ADV + 1

Work from home option

Résumé du poste

Randstad Belgium is seeking a Quality Systems Analyst to independently review nonconformities and CAPAs within the CAR-T Belgium organization, coaching investigation teams to ensure quality assessments align with global and local procedures.

Operating as part of the Quality Systems team, this role emphasizes coaching, documentation, and strict adherence to cGMP and ICH guidelines, while supporting safety and compliance across projects.

Qualifications

• Master’s degree in a scientific or technical field (Analytics, Chemistry, Biotechnology, Pharmaceutical Sciences, Engineering) or equivalent experience.
• Minimum of 5 years of experience in Quality Systems or Quality Assurance related to manufacturing.
• Strong knowledge and understanding of cGMP regulations related to sterile manufacturing, as well as ICH guidelines, policies, and standards.
• Solid understanding of Quality Systems processes, specifically nonconformity and CAPA handling.
• Proven experience in coaching personnel, paired with strong analytical thinking and clear verbal/written communication skills.
• Highly organized, capable of working under daily supervision in a team environment with a positive attitude.
• Fluent in English (written and spoken).
• Familiarity with COMET, Truvault, SUMMIT, and MS Office.

Responsabilités

• Investigation Review: Perform end-to-end reviews of nonconformity risk assessments and CAPA investigations in compliance with global and local procedures.
• Cross-Functional Collaboration: Partner with investigation teams and QA members to guarantee investigations and risk assessments are thoroughly and properly documented.
• Coaching & Mentorship: Coach personnel involved in the Nonconformity and CAPA handling process on best investigational practices.
• Timely Delivery: Coordinate with team members and process stakeholders to ensure reviews are completed in a timely manner.
• Compliance & Standards: Execute all tasks in alignment with cGMP requirements, quality systems, and safety policies.
• Monitor compliance with legal requirements in partnership with the SHE department.
• Adhere strictly to prevention rules and safety procedures.
• Actively participate in safety promotion and awareness campaigns.
• Promptly report any accidents, incidents, damages, or unsafe/environmentally harmful situations to senior leadership.
• Propose solutions to prevent unsafe conditions (e.g., via suggestion forms, accident investigations, and safety committee participation).
• Salary, bonus & rewards, Our offer; competitive gross salary with 13th month and double holiday pay; monthly net allowance

Connaissances

Coaching

Communication

Analytical thinking

Formation

Master’s degree in a scientific or technical field

Outils

COMET

Truvault

SUMMIT

MS Office

Description du poste

The Quality Systems Analyst is responsible for the independent review of nonconformities and Corrective and Preventive Actions (CAPAs) within the CAR-T Belgium organization. Operating as part of the Quality Systems team, this role plays a key part in coaching investigation teams to ensure all quality assessments and documentations align strictly with global and local procedural requirements.

Qualifications

• Education: Master’s degree in a scientific or technical field (Analytics, Chemistry, Biotechnology, Pharmaceutical Sciences, Engineering) or equivalent experience.
• Experience: Minimum of 5 years of experience in Quality Systems or Quality Assurance related to manufacturing.
• Domain Knowledge: Strong knowledge and understanding of cGMP regulations related to sterile manufacturing, as well as ICH guidelines, policies, and standards.
• Process Expertise: Solid understanding of Quality Systems processes, specifically nonconformity and CAPA handling.
• Coaching & Communication: Proven experience in coaching personnel, paired with strong analytical thinking and clear verbal/written communication skills.
• Personal Traits: Highly organized, capable of working under daily supervision in a team environment with a positive attitude.
• Languages: Fluent in English (written and spoken).
• Systems: Familiarity with COMET, Truvault, SUMMIT, and MS Office.

Key Responsibilities

Quality Systems & QA Responsibilities

• Investigation Review: Perform end-to-end reviews of nonconformity risk assessments and CAPA investigations in compliance with global and local procedures.
• Cross-Functional Collaboration: Partner with investigation teams and QA members to guarantee investigations and risk assessments are thoroughly and properly documented.
• Coaching & Mentorship: Coach personnel involved in the Nonconformity and CAPA handling process on best investigational practices.
• Timely Delivery: Coordinate with team members and process stakeholders to ensure reviews are completed in a timely manner.
• Compliance & Standards: Execute all tasks in alignment with cGMP requirements, quality systems, and safety policies.
• Monitor compliance with legal requirements in partnership with the SHE department.
• Adhere strictly to prevention rules and safety procedures.
• Actively participate in safety promotion and awareness campaigns.
• Promptly report any accidents, incidents, damages, or unsafe/environmentally harmful situations to senior leadership.
• Propose solutions to prevent unsafe conditions (e.g., via suggestion forms, accident investigations, and safety committee participation).
• Salary, bonus & rewards,
• Our offer
• competitive gross salary with 13th month and double holiday pay
• monthly net allowance
• choice between company car with fuel/charging card (SalSa plan) or mileage reimbursement for using your own car
• hospitalization insurance from day 1 + optional outpatient insurance (incl. dental care)
• group insurance (pension savings)
• cafeteria plan (Flex Income Plan)
• 4 weeks of statutory holiday + 12 ADV days + seniority leave
• possibility to work from home (depending on project)
• Benefits at Work discount platform
• referral bonus when you recommend a new colleague
• personal follow-up via account manager, HR/L&D support, access to training, learning tools and certifications
• networking events and internal activities to stay connected with colleagues and the organisation
• Prefer to work as a freelance consultant?
• we pay your invoices on time and correctly (30 days)
• our team of recruiters and account managers is closely involved in your career and follows you up
• towards the end of your project, we proactively look for your next assignment