Overview
Quality Systems Analyst Jobs in Ghent, Flemish Region, Belgium at Randstad
Title: Quality Systems Analyst
Company: Randstad
Location: Ghent, Flemish Region, Belgium
Position Overview
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.
Safety, Health & Environment (SHE) Responsibilities
- 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).
Benefits
- Salary, bonus & rewards,
- Our offer
- competitive gross salary with 13th month and double holiday pay
- monthly net allowance
- meal vouchers & eco vouchers
- 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
