GMP QA Specialist - Onsite Production & Compliance

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

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