On-site QC Lead – GMP, CAPA & Compliance

Prothya Biosolutions Netherlands B.V; Netherlands; Remote; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Flexible hours

30 days holiday

Training budget €2,100 every 3 years

Travel allowance

Pension plan Zorg & Welzijn

Challenging environment with growth

Job summary

Prothya Biosolutions Netherlands B.V in the Netherlands is seeking a QC Officer to uphold GMP standards, perform investigations, and drive data integrity across QA processes. You will collaborate with colleagues to prevent recurrence and ensure compliant product releases.

The role requires a Master or Bachelor in Analytical Chemistry or Pharmaceutical Sciences with 5+ years in analytical chemistry, microbiology, or incoming goods in a QC environment in pharma/biotech.

Qualifications

• Bachelor or Master in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• >5 years in analytical chemistry and/or microbiology and/or incoming goods in a QC environment in pharma/biotech.
• Experience in deviation management, investigations, root cause analysis, and corrective/preventive actions.

Responsibilities

• Demonstrates independent understanding and application of GMP fundamentals, including GMP, GDP, and data integrity.
• Perform investigations on non-conformances, deviations, and OOS results; apply root cause analysis tools.
• Conduct routine audits to ensure GMP compliance and quality standards.
• Support and guide lab personnel in quality control practices and regulatory requirements.
• Collaborate with cross-functional teams to facilitate product release and resolve quality issues.
• Assist in identifying and implementing improvements.

Skills

GMP Fundamentals

Investigations

CAPA leadership

Root cause analysis

Documentation

Quality control

Analytical chemistry

Microbiology

Regulatory requirements

Communication

Education

Bachelor or Master in Analytical Chemistry/Pharmaceutical Sciences

Tools

Measuring equipment

Qualification & maintenance

Job description

Prothya Biosolutions Netherlands B.V in the Netherlands is seeking a QC Officer to uphold GMP standards, perform investigations, and drive data integrity across QA processes. You will collaborate with colleagues to prevent recurrence and ensure compliant product releases.

The role requires a Master or Bachelor in Analytical Chemistry or Pharmaceutical Sciences with 5+ years in analytical chemistry, microbiology, or incoming goods in a QC environment in pharma/biotech.