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QC Engineer Specialist - Method Validation
Prothya Biosolutions Netherlands B.V.
What you'll do
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.
Continuous Improvement
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.
What you'll bring
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's on 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.