QC Engineer Specialist - Method Validation

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

As a QC Engineer Specialist you support the Quality Control Operations lab team with method validation, verification, transfer, troubleshooting and specification setting.

Key responsibilities:

Method verification/validation

• Perform and coordinate method development and validation/verification: Develop and implement methods in the QC lab following Analytical Quality by Design (AQbD ) principles and international guidelines.
• Write method validation/ verification protocols and reports.
• Driving continuous improvement initiatives within, processes, and procedures to enhance efficiency, effectiveness, and compliance while reducing risk.
• Staying up to date with developments in the pharmaceutical industry regarding analytical/microbiological techniques.

Review of GxP Standards

• Reviewing and ensuring compliance with Good Manufacturing Practice (GMP) standards, as applicable to the organization's activities, to maintain product quality and regulatory compliance.
• Staying updated of relevant regulatory requirements and industry standards to ensure that quality systems and processes remain compliant and up to date.

SME (Subject Matter Expert)

• Act as SME in the field of Analytical (Bio) QC methods.

Your skills and experience:

• Bachelor or Masters degree in analytical chemistry or relevant subject, with at least 3 years of experience with analytical assays (chromatography) in a GMP laboratory environment.
• Knowledge and interpretation of Ph.Eur. General Notices, ICH Q2 & Q14, and Eudralex GMP Guidelines. As well as general AQbD principles.
• Root cause analysis investigation capabilities, leading to the identification of potential problems ability to suggest improvements.
• Risk assessment knowledge (for instruments, methods, raw materials, compliance).
• Specification-setting for raw materials in collaboration with production requirements and with pharmacopoeial compliance in mind.
• Change control process experience, including justification and setup of small and medium changes and definition of the required tasks and timelines.
• Method and instrument troubleshooting knowledge (HPLC, GC, ICP, and simpler tests).
• Experience with deviation management and resolution via root cause analysis and risk assessments, as well as CAPA implementation and effectiveness check follow ups.
• Project management mindset to ensure proper collaboration and communication between relevant parties.
• Hands on experience in a GxP laboratory: sample preparation, measurement, and documentation as well as peer review of analytical data.
• Quality mindset and project management experience is preferred.
• Stress-resistant, enthusiastic and proactive mentality to get things done.
• Strong communication and collaboration skills with different stakeholders, a real team player.
• Demonstrate excellent written and oral communication skills in English, with proficiency in Dutch being a plus.

What we offer:

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• Salary between € 4.702,26 and € 6.759,41 gross per month (based on full-time employment).
• 8.33% holiday allowance and a 13th month payment.
• 30 holiday days (based on fte).
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.