QA Qualification Specialist

Our client is seeking a Qualification Specialist to strengthen their Quality Assurance team within their production and continuous improvement activities. You will contribute to ensuring that equipment and systems comply with current quality and regulatory requirements.

Our client is a recognised international player operating in a high-tech and heavily regulated environment. The company places quality, innovation, and operational excellence at the heart of its activities.

Responsibilities

• Define and implement qualification strategies for equipment and systems.
• Write, review, and approve qualification protocols and reports (IQ, OQ, PQ).
• Ensure the qualification of production equipment and associated utilities.
• Collaborate with Quality, Engineering, Validation, and Production teams.
• Participate in risk analyses and quality impact assessments.
• Ensure compliance with GMP/GxP requirements and internal procedures.
• Contribute to the management of deviations, investigations, and corrective action plans.
• Participate in the review and approval of technical and quality documentation.
• Monitor qualification activities with stakeholders.
• Provide quality support for projects involving the evolution of facilities and equipment.
• Participate in internal audits and regulatory inspections when required.

Candidate Profile

• Engineering degree or university education in sciences, pharmacy, or an equivalent discipline.
• Proven experience in qualification within the pharmaceutical or medical device industry.
• Strong knowledge of equipment and system qualification activities.
• Mastery of GMP/GxP requirements.
• Experience with critical systems and/or specialised equipment.
• Knowledge of Computer System Validation (CSV) activities is an asset.
• Ability to work in a regulated and multidisciplinary environment.
• Excellent organisational and priority management skills.
• Analytical mindset and attention to detail.
• Good communication and collaboration skills.
• Fluent in French and professional level in English.

Terms and Benefits

• Temporary assignment within an internationally recognised environment for its excellence.
• Exposure to varied activities in a demanding and stimulating quality context.
• Collaboration with expert and multidisciplinary teams.