Quality Assurance Engineer

agap2 Switzerland; Basel; Presencial; CHF 95.000 - 130.000; Jornada completa

Descripción de la vacante

agap2 Switzerland is seeking a quality-focused consultant to support biotech and biopharmaceutical clients on site in Basel. You will bring expertise in QMS, GMP, and regulatory standards to ensure compliant manufacturing and release processes.

The role requires collaboration across cross-functional teams in an international environment, fluency in English and German, and a proactive approach to audits, CAPA, and continuous improvement.

Formación

• Degree in Pharmacy (PharmD), Engineering, Biotechnology, or Quality Management.
• Experience in biotechnology or biopharmaceutical industry.
• Knowledge of cGMP regulations and quality standards.

Responsabilidades

• Maintain and improve the Quality Management System (QMS).
• Prepare batch release documentation and review batch records.
• Draft, review, and approve GMP documentation.
• Review biotechnology process validation docs (plans, protocols, reports).
• Manage quality events: CAPA, deviations, OOS, complaints.
• Oversee subcontractors and CMOs quality activities.
• Develop and maintain quality procedures and SOPs.
• Prepare APQRs (Annual Product Quality Reviews).
• Conduct internal audits and support regulatory inspections.

Conocimientos

Quality systems knowledge

Regulatory compliance

Biotechnology manufacturing

GMP knowledge

Cross-functional collaboration

English & German fluency

Educación

PharmD / Degree in Pharmacy

Biotechnology degree

Quality management degree

Descripción del empleo

agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.

Main Responsibilities

• Ensure the maintenance and continuous improvement of the Quality Management System (QMS)
• Prepare batch release documentation, including detailed review of batch records
• Draft, review, and approve GMP-related documentation
• Review and approve biotechnology process validation documentation (validation plans, protocols, and reports)
• Manage quality events and systems such as Change Controls, Deviations, CAPA, OOS investigations, and customer complaints
• Oversee quality activities related to subcontractors and CMOs, including qualification and performance monitoring
• Develop, update, and maintain quality procedures and SOPs
• Prepare Annual Product Quality Reviews (APQRs)
• Conduct internal audits and provide support during regulatory inspections

Your Profile

• Degree in Pharmacy (PharmD), Engineering, Biotechnology, or Quality Management
• Prior experience within the biotechnology or biopharmaceutical industry
• Strong understanding of biotechnological manufacturing processes, including USP, DSP, and Fill & Finish operations
• Good knowledge of cGMP regulations and quality standards
• Comfortable working in an international and cross-functional environment
• Fluency in both English and German, written and spoken, is mandatory

Thank you for your interest in this opportunity. Please note that only candidates selected for an initial interview will be contacted.