Method Validation QC Expert

Diepenbeek - Belgium

Monthly Salary: Not Disclosed

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

As Method Validation QC Expert you ensure the scientific and regulatory robustness of all analytical validation activities at simAbs. You design execute and oversee assay validation plans to guarantee data integrity compliance and reliability essential foundations for our biologics development and manufacturing programs. Your expertise also supports analytical requirements specific to biosimilars including comparability and characterization studies.

Responsibilities

Define and execute method validation strategies in line with ICH and GMP guidelines.

Draft validation protocols and reports review raw data and ensure data integrity.

Coordinate with QC Analytical Development and external laboratories to ensure consistent validation practices.

Troubleshoot technical challenges and provide expert guidance to project teams.

Support process changes with comparability assessments.

Manage deviations CAPAs and improvement initiatives related to analytical performance.

Communicate validation progress and findings to stakeholders clearly and proactively.

Vereisten

Qualifications

Masters or PhD in Life Sciences Analytical Chemistry or Biotechnology.

Proven experience in analytical method validation in a regulated biopharma or biotech setting.

Strong understanding of GMP ICH Q2(R2) and analytical quality systems.

Strong knowledge of biosimilar analytical requirements and hands-on experience with validation or comparability assessments for biosimilars (highly valued).

Competences

Analytical and detail-oriented mindset.

Expertise in statistical validation principles and data interpretation.

Excellent documentation and reporting skills.

Capable of managing multiple validation projects simultaneously.

Motivated by science quality and innovation in a collaborative start-up environment.