Quality Assurance Officer
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Why this role matters
As a Quality Assurance Officer at Inteliphage, you will report to the Head of Quality, you will make sure our equipment, processes and production activities comply with GMP requirements. You will work closely with our Production, QC and Engineering teams, both on project implementation and day-to-day operations.
What your days could look like
QA Operations
- Act as the QA point of contact for production teams and provide day-to-day support on the floor
- Carry out GMP walk-throughs and support internal audits and regulatory inspections
- Promote a strong quality culture and train staff on GMP principles and procedures
- Review executed batch records and production documentation
- Manage and assess deviations, CAPAs and change Manage and assess deviations, CAPAs and change controls
Equipment Qualification
- Take part in the qualification of equipment, utilities and facilities, following a risk-based approach
- Review and approve qualification documents: User Requirement Specifications (URS), Validation Plans (VP), and IQ/OQ/PQ protocols and reports
- Assess deviations and non-conformities that arise during qualification, and follow up on corrective actions
- Help maintain the qualified status of equipment (periodic reviews, change control, requalification)
Production Processes and Procedures
- Help set up and roll out GMP-compliant production processes
- Write, review and approve SOPs, work instructions, forms and batch records
- Help build and continuously improve the Quality Management System (QMS)
What you bring to the table
You ideally bring:
- At least a Bachelor's degree in sciences (biology, biotechnology, chemistry, pharmacy, bioengineering or similar)
- +3 years of experience in Quality Assurance in a GMP-regulated environment (pharma, biotech, ATMP or similar)
- Good knowledge of EU GMP (EudraLex Volume 4) and its annexes, especially Annex 1 and Annex 15
- Hands-on experience with equipment qualification and validation documents (URS, IQ/OQ/PQ)
- Structured, detail-oriented and pragmatic, with the ability to find compliant solutions that work in practice
- Good communication skills and comfortable working in the field alongside operational teams
- Fluent in French and ability to use English for understanding and writing procedures
- MUST have a valid work permit for Belgium.
- Work to be performed mainly on site
Ready to make an impact?
We’d love to hear your story. Apply today
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