Senior QA Validation Lead – cGMP & Validation Expert

Prothya Biosolutions (operating under Accord Plasma B.V. / Intas Pharmaceuticals); Brussel Hoofdstad; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health insurance

Meal vouchers

Eco-cheques

Flex Reward Plan

1 day homeworking after onboarding

Résumé du poste

Prothya Biosolutions, a Belgium-based biopharmaceutical company, seeks a Senior Quality Engineer to safeguard quality by overseeing qualification and validation protocols from a QA perspective. You will review validation protocols and reports and draft validation tests for equipment, utilities, IT, cleaning, and process validation.

You will lead quality-related projects and act as the primary QA SPOC for project teams, while coaching junior QA validation staff and promoting adherence to pharma

Qualifications

• Master's degree in a relevant field is required.
• 6–10 years of experience in pharma/food sectors in QA/validation.
• Familiarity with European and US GMP guidelines and SOPs is a plus.
• Proficiency with MS Office and QA systems (SAP, MasterControl).
• Knowledge of Good Documentation Practices, Data Integrity and Computer Systems Validation.
• Experience with sterilisation validation in QA or Engineering.

Responsabilités

• Oversee qualification and validation protocols from a QA perspective.
• Draft and review validation reports and protocols for equipment and utilities.
• Lead quality-related projects and act as SPOC for project teams.
• Provide coaching to junior QA validation staff and educate on quality and pharma rules.
• Support IT validation, cleaning validation and process validation.

Connaissances

Quality Assurance

Validation

GMP

Project leadership

SPOC

English fluency

Dutch/French knowledge

Formation

Master's degree in chemistry/industrial pharmacy/biotechnology

Outils

SAP

MasterControl

Description du poste

Prothya Biosolutions, a Belgium-based biopharmaceutical company, seeks a Senior Quality Engineer to safeguard quality by overseeing qualification and validation protocols from a QA perspective. You will review validation protocols and reports and draft validation tests for equipment, utilities, IT, cleaning, and process validation.

You will lead quality-related projects and act as the primary QA SPOC for project teams, while coaching junior QA validation staff and promoting adherence to pharma