QC Engineer Specialist - Method Validation & GxP SME

Prothya Biosolutions; Amsterdam; On-site; EUR 52,000 - 75,000; Full time

Benefits offered by this job

40h work week with flexible hours

Salary between €4,702.26 and €6,759.41

8.33% holiday allowance and 13th month

30 holiday days

Training budget €2,100 every three yea

Travel expense contribution from first

Public transport accessibility and car

Pension plan

Job summary

Prothya Biosolutions is seeking a QC Engineer Specialist to support the QC Operations lab with method validation/verification, transfer, and specification setting. You will drive continuous improvements and ensure GMP compliance while staying current with industry standards.

The role requires a 3+ year background in analytical chemistry within GMP labs, expertise in chromatographic methods (HPLC/GC/ICP) and strong problem-solving abilities.

Qualifications

• Bachelor or Master in analytical chemistry or relevant subject.
• 3+ years of experience with analytical assays (chromatography) in GMP labs.
• Knowledge of Ph.Eur., ICH Q2/Q14 and AQbD principles.
• Strong problem solving with root cause analysis and CAPA follow-up.

Responsibilities

• Lead method verification/validation and transfer in QC labs.
• Write validation/verification protocols and reports.
• Drive improvements to efficiency, compliance and risk reduction.
• Ensure GMP compliance and regulatory updates in quality systems.
• Act as SME for Analytical (Bio) QC methods.

Skills

Analytical chemistry

GxP mindset

HPLC

GC

ICP

Root cause analysis

Change control

Documentation

Team collaboration

English communication

Education

Bachelor or Master in analytical chemistry

Tools

HPLC

GC

ICP

Job description

Prothya Biosolutions is seeking a QC Engineer Specialist to support the QC Operations lab with method validation/verification, transfer, and specification setting. You will drive continuous improvements and ensure GMP compliance while staying current with industry standards.

The role requires a 3+ year background in analytical chemistry within GMP labs, expertise in chromatographic methods (HPLC/GC/ICP) and strong problem-solving abilities.