Medior/senior) QA/qc Analytical Validation Specialist
il y a 3 jours
Success of Engineering Projects mostly relies on key individuals demonstrating Intrapreneurial Leadership, and the best way to develop these skills is through hands-on consulting roles—working alongside established intrapreneurs in international companies, contributing to managing stakeholders' engagement, workflows' reliability, or solutions' sustainability.
You know how one unnoticed deviation in a GMP environment can compromise an entire production batch, delay regulatory approvals, and erode trust. As a specialist, you’ve probably faced these critical moments where precision and vigilance were the only safeguards against operational and reputational damage.
We would therefore welcome you at AETHER to support Intrapreneurial Projects, as a senior QA/QC Analytical Validation Specialist:
The scope, here, is to strengthen pharmaceutical and biotech projects by ensuring robust analytical methods and supporting the integrity of quality systems.
The key responsibilities expected from our consultant might include:
Support projects through high-quality and detail-oriented execution, ensuring accuracy and meeting expectations:
- Develop analytical methods (HPLC, GC, spectroscopy) in compliance with GMP.
- Draft validation protocols, reports, and SOPs.
- Analyze quality performance indicators (KPIs).
Support projects with rational and data-driven assessments regarding costs, quality, and timelines, providing objective analyses for decision-making:
- Validate analytical methods (HPLC, GC, spectroscopy) in compliance with GMP.
- Review validation protocols, reports, and SOPs.
- Critically review analytical data and ensure data integrity.
- Monitor quality performance indicators (KPIs).
- Participate in internal audits and support external regulatory inspections.
Support projects by facilitating communication and reporting between stakeholders:
- Manage deviations, OOS/OOT results, and support quality investigations.
- Collaborate with R&D, Production, and QA teams for method transfers and equipment qualification (IQ/OQ/PQ).
The experience we are actively looking for:
- Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or equivalent.
- Minimum 5 years of QA/QC analytical experience within a GMP-regulated environment (pharma or biotech).
- Proficiency in analytical techniques (HPLC, GC, UV, dissolution), method validation, and equipment qualification.
- Strong understanding of GMP, data integrity, and quality systems.
- Detail-oriented, proactive, with strong analytical thinking and effective communication skills.
- Fluent in French and English (written and spoken).
- Immediate availability and presence in Belgium are preferred.
Your best career choice will be one that propels you toward becoming a future intrapreneur or entrepreneur in your field of expertise.
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