QA Specialist, GMP & Lifecycle Impact (Hybrid NL)

TRIUM Clinical Consulting NV; Zuid-Holland; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

TRIUM Clinical Consulting NV is seeking a Quality Assurance Specialist to join the Hybrid, NL team. You will generate and maintain quality records, prepare reports, conduct risk assessments, and investigate deviations with CAPA to ensure product and process quality.

The role involves collaboration across functions, audits, and continuous improvement in GMP environments. Fluency in Dutch and English is essential.

Qualifications

• Bachelor or Master degree in pharmacy, bioengineering, biomedical sciences, or applied sciences.
• Hands-on experience in QA in a GMP environment, preferably in a commercial GMP manufacturing setting.
• Eye for detail and product quality; structured, flexible and stress resistant.
• Proactive, results-oriented, and team-oriented.
• Fluent Dutch and English verbally and in writing.

Responsibilities

• Generate, and maintain Quality records in support of the Quality Systems.
• Prepare detailed reports and present data-driven recommendations to management and stakeholder.
• Conduct risk assessments and proactively identify critical process parameters and potential failure points.
• Investigate deviations, non-conformities, and customer complaints using root cause analysis and CAPA.
• QA batch record review, support materials release and support batch release process.
• Support regular audits and inspections to verify processes comply with internal standards and external regulations.
• Collaborate cross-functionally to design, validate, and optimize processes that meet quality attributes.
• Ensure quality requirements are incorporated from development through production, supporting lifecycle management.
• Keep knowledge up to date with latest guidelines, methodologies, and trends.

Skills

GMP QA experience

Quality systems

Data analysis

Cross-functional

Dutch & English

Education

Bachelor/Master in Pharmacy

Job description

TRIUM Clinical Consulting NV is seeking a Quality Assurance Specialist to join the Hybrid, NL team. You will generate and maintain quality records, prepare reports, conduct risk assessments, and investigate deviations with CAPA to ensure product and process quality.

The role involves collaboration across functions, audits, and continuous improvement in GMP environments. Fluency in Dutch and English is essential.