GMP QC Investigator - Analytical Chemistry, Flexible Hours

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

Benefits offered by this job

8.33% end-of-year bonus

8.33% holiday allowance

Training budget €2,100 every three yrs

Travel expense reimbursement

Public transport accessibility and/or/

Job summary

Prothya Biosolutions Netherlands B.V. is seeking a QC Officer to strengthen Quality Control Operations in analytical chemistry. The role emphasizes GMP adherence, investigations, and ongoing improvements in a collaborative, on-site setting.

The ideal candidate brings a strong background in analytical chemistry within pharma/biotech QC, with experience in deviation handling, root-cause analysis and CAPA, plus solid data integrity and regulatory knowledge.

Qualifications

• Bachelor or Master degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• >5 years work experience within analytical chemistry in a QC environment in the pharmaceutical or biotech industry.
• Experience in deviation management, investigations, root cause analysis and CAPA actions.
• Ability to lead investigations and manage CAPA processes.
• Strong understanding of GMP and regulatory requirements.

Responsibilities

• Demonstrates independent understanding and application of GMP fundamentals, including Good manufacturing practices, good documentation practice and data integrity.
• Perform investigations on non-conformances, deviations, and out-of-specification (OOS) results; root cause analysis.
• Conduct routine audits to ensure GMP and quality standards compliance.
• Support and guide laboratory 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 knowledge

Documentation practices

Data integrity

Investigation & root cause analysis

CAPA management

Regulatory requirements

Analytical thinking

Communication skills

Cross-functional collaboration

English proficiency

Education

Bachelor's or Master's in Analytical Chemistry / Pharmaceutical Sciences

Tools

Measuring equipment qualification

Job description

Prothya Biosolutions Netherlands B.V. is seeking a QC Officer to strengthen Quality Control Operations in analytical chemistry. The role emphasizes GMP adherence, investigations, and ongoing improvements in a collaborative, on-site setting.

The ideal candidate brings a strong background in analytical chemistry within pharma/biotech QC, with experience in deviation handling, root-cause analysis and CAPA, plus solid data integrity and regulatory knowledge.