Quality Assurance Officer - GMP Operations

Biopark; Belgique; Remote; EUR 60,000 - 86,000; Full time

Job summary

Biopark is seeking a Quality Assurance Officer to join our GMP operations team in Belgium. You will ensure processes, equipment and production activities comply with GMP requirements, working closely with Production, QC and Engineering teams on project implementations and daily operations.

The role emphasizes on-site presence, QA on the floor, document reviews, and continuous improvement of the QMS. Fluency in French and English for procedures is required, with a valid Belgium work permit

Qualifications

• Bachelor's degree in sciences required.
• 3+ years of QA experience in a GMP-regulated environment (pharma/biotech).
• Strong knowledge of EU GMP (EudraLex Volume 4) and Annexes 1 & 15.
• Hands-on experience with equipment qualification and validation documents (URS/IQ/OQ/PQ).
• Structured, detail-oriented with ability to implement compliant practical solutions.
• Good communication skills and field-work readiness.
• Fluent in French with ability to use English for procedures writing.
• Must have valid work permit for Belgium.

Responsibilities

• 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 controls.
• Participate in qualification of equipment, utilities and facilities following a risk-based approach.
• Review and approve qualification documents (URS, VP, IQ/OQ/PQ reports).
• Assess deviations during qualification and follow up on corrective actions.
• Maintain the qualified status of equipment with periodic reviews and change controls.
• Assist in setting up and rolling out GMP-compliant production processes.
• Write, review and approve SOPs, work instructions, forms and batch records.
• Contribute to the ongoing improvement of the Quality Management System (QMS).

Skills

GMP QA

Audit support

CAPA management

Batch records review

Quality culture

Education

Bachelor's degree in sciences

Tools

URS IQ/OQ/PQ docs

Validation knowledge

Job description

Quality Assurance Officer - GMP Operations Inteliphage

In a regulated GMP/GxP environment, quality is at the heart of every process, every decision, and every product delivered.As a Quality Assurance Specialist, you play a key role in ensuring compliance across the full product lifecycle, from R&D to production. You help maintain the highest quality standards, secure operations, and strengthen trust with regulatory authorities, partners, and ultimately, patients.

As a Quality Assurance Officerat 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 changeManage 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.