GMP QA Specialist: Equipment Qualification & Processes

The Phage; Belgique; Remote; EUR 50,000 - 70,000; Full time

Job summary

Inteliphage is seeking a Quality Assurance Officer to join the Quality team, collaborating closely with Production, QC, and Engineering to ensure GMP compliance across processes and equipment.

You will participate in equipment qualification, QMS improvements, audits, staff training, and the implementation of GMP-compliant processes, with a focus on documentation and continuous quality enhancement.

Qualifications

• Bachelor’s degree or higher in Biology, Biotechnology, Chemistry, Pharmacy, Bioengineering, or a related scientific discipline.
• At least 3 years of Quality Assurance experience in a GMP-regulated environment such as pharmaceutical, biotechnology, ATMP, or a related industry.
• Good knowledge of EU GMP (EudraLex Volume 4) and relevant GMP annexes, particularly Annex 1 and Annex 15.
• Practical experience with equipment qualification and validation documentation (URS/IQ/OQ/PQ).
• Experience with deviations, CAPAs, change controls, and quality documentation.
• Strong understanding of GMP principles and quality systems.
• Structured and detail-oriented with strong documentation and writing skills.
• Fluency in French; ability to read and write procedures in English.

Responsibilities

• Act as the QA point of contact for production teams and provide day-to-day GMP support.
• Conduct GMP walkthroughs and support internal audits and regulatory inspections.
• Promote a strong quality culture and provide GMP training.
• Review batch records and production documentation.
• Manage and assess deviations, CAPAs, and change controls.
• Collaborate with Production, QC, Engineering, and Quality teams to maintain GMP compliance.

Skills

Quality Assurance

GMP compliance

Documentation

CAPA management

Deviations handling

Audit support

SOP writing

Interpersonal skills

Cross-functional collaboration

French fluent

Education

Biology/biotechnology/chemistry degree

Tools

URS

IQ/OQ/PQ

Validation Plans

QA documentation

Job description

Inteliphage is seeking a Quality Assurance Officer to join the Quality team, collaborating closely with Production, QC, and Engineering to ensure GMP compliance across processes and equipment.

You will participate in equipment qualification, QMS improvements, audits, staff training, and the implementation of GMP-compliant processes, with a focus on documentation and continuous quality enhancement.