QC Investigator – GMP & Operations (Flexible Hours)

Prothya Biosolutions; Amsterdam; On-site; EUR 47,000 - 67,000; Full time

Benefits offered by this job

40 h work week

Holiday allowance 8.33%

13th month pay

30 holiday days

Training budget €2,100 every 3 years

Travel expense contribution

Public transport access

Pension plan Zorg & Welzijn

Job summary

Prothya Biosolutions is seeking a Quality Control Officer to uphold GMP standards and drive investigations into deviations and OOS results. You will lead CAPA activities and work closely with QC labs and cross-functional teams to ensure compliant product releases.

This role emphasizes on-site collaboration, rigorous documentation, and strong communication in English and Dutch. A Master or Bachelor in analytical science is required, with 5+ years in QC environments within pharma/biotech.

Qualifications

• Bachelor or Master degree in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• 5+ years work experience within analytical chemistry and/or microbiology and/or incoming goods in a QC environment in the pharmaceutical or biotech industry.
• Experience in deviation management, investigations, root cause analysis and corrective actions.
• Ability to lead investigations and manage CAPA processes.
• Strong understanding of GMP and regulatory requirements.
• Experience with measuring-equipment qualification and maintenance.
• Analytical thinking and problem-solving abilities.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Articulate written and oral communication, able to deliver messages clearly.
• Proficiency in documentation practices and attention to detail.
• Ability to work under stress and prioritize tasks.
• Team player mindset for supporting colleagues.
• Strong grasp of English and Dutch (conversational).
• Ability to work fully on-site.

Responsibilities

• Demonstrates independent understanding and application of GMP fundamentals and data integrity.
• Perform investigations on non-conformances, deviations, and OOS results with root cause analysis.
• Conduct routine audits to ensure GMP compliance.
• Support and guide laboratory personnel in QC 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 knowledge

Root cause analysis

CAPA processes

Analytical thinking

Communication skills

Documentation practices

Team player

Dutch language

English language

On-site work

Education

Bachelor or Master in Analytical Chemistry, Pharmaceutical Sciences, or related field

Tools

Measuring equipment qualification

Laboratory maintenance

Job description

Prothya Biosolutions is seeking a Quality Control Officer to uphold GMP standards and drive investigations into deviations and OOS results. You will lead CAPA activities and work closely with QC labs and cross-functional teams to ensure compliant product releases.

This role emphasizes on-site collaboration, rigorous documentation, and strong communication in English and Dutch. A Master or Bachelor in analytical science is required, with 5+ years in QC environments within pharma/biotech.