QA qualification engineer

Agap2 seeks a Mid-level QA Qualification Engineer in Basel to support client projects with expertise in equipment qualification and regulatory compliance.

This position focuses on assisting clients in executing on-site projects by applying specialized knowledge and technical skills. The role demands agility and adaptability to various work environments, encouraging a deep curiosity about significant client initiatives.

Responsibilities

• Evaluate and approve IQOQ/PQ protocols and reports for production equipment and utilities.
• Ensure all activities adhere to applicable regulations such as GMP, USP, and Ph. Eur.
• Offer technical guidance and support to project teams.
• Take part in equipment qualification meetings and review sessions.
• Keep precise records and maintain thorough documentation.
• Assist with internal and external audit processes.
• Monitor and stay updated on relevant industry standards and regulatory changes.

Requirements

• Master's degree in Biotechnology or a closely related discipline.
• At least three years of experience in QA for qualification within pharma, biotech, or medtech sectors.
• Fluent proficiency in English.
• Swiss or EU nationality.

About the company

Founded in 2005, agap2 is a European engineering and operational consulting group specializing in industrial sectors. The firm operates across diverse industries including Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology.

• Specialized expertise in industrial engineering and operational consulting.
• Broad industry presence spanning multiple high-tech sectors.