Quality Assurance Officer Opportunity At Inteliphage

Inteliphage is looking for a Quality Assurance Officer to join its Quality team and work closely with Production, Quality Control (QC), and Engineering teams.

The Quality Assurance Officer will support GMP compliance across equipment, production processes, documentation, and day-to-day operations. The role also involves contributing to equipment qualification, QMS improvement, audits, staff training, and the implementation of GMP-compliant processes.

Key Responsibilities

QA Operations

• 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 training on GMP principles and procedures.
• Review executed batch records and production documentation.
• Manage and assess deviations, CAPAs, and change controls.
• Work closely with Production, QC, and Engineering teams to maintain GMP compliance.

Equipment Qualification

• Participate in the qualification of equipment, utilities, and facilities using a risk-based approach.
• Review and approve qualification documents, including:
  • User Requirement Specifications (URS)
  • Validation Plans (VP)
  • IQ/OQ/PQ protocols and reports
• Assess deviations and non-conformities identified during qualification activities.
• Follow up on corrective actions and ensure appropriate resolution.
• Support periodic reviews, change controls, and requalification activities to maintain the qualified status of equipment.

Production Processes & Procedures

• Support the implementation of GMP-compliant production processes.
• Write, review, and approve:
  • Standard Operating Procedures (SOPs)
  • Work instructions
  • Forms
  • Batch records
• Contribute to the development and continuous improvement of the Quality Management System (QMS).

Qualifications & Skills Required

• 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 – Manufacture of Sterile Medicinal Products
  • Annex 15 – Qualification and Validation
• Practical experience with equipment qualification and validation documentation, including URS, IQ, OQ, and PQ.
• Experience with deviations, CAPAs, change controls, and quality documentation.
• Strong understanding of GMP principles and quality systems.
• Structured and detail-oriented approach to work.
• Ability to identify compliance issues and develop practical, compliant solutions.
• Strong documentation and technical writing skills.
• Good communication and interpersonal skills.
• Comfortable working directly with operational and production teams.
• Ability to work collaboratively with Production, QC, Engineering, and Quality teams.
• Fluency in French, ability to read and write procedures in English.

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