QA qualification engineer

agap2 Switzerland; Basel; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

agap2 Basel seeks a qualified QA professional to support pharma/biotech projects on site, ensuring QA/QC for qualification activities and adherence to regulatory standards.

The role requires a Master’s in Biotechnology, 3+ years in pharma/biotech QA, and fluency in English. This Basel-based position offers on-site collaboration with client teams and exposure to industry-leading projects.

Qualifikationen

• Master's degree in Biotechnology or related field.
• Minimum 3 years QA experience in pharma/biotech/medtech.
• Fluent in English.
• Swiss or EU nationality.

Aufgaben

• Review and approve IQOQPQ protocols and reports.
• Ensure GMP, USP, Ph. Eur. compliance.
• Provide technical guidance to project teams.
• Participate in equipment qualification meetings.
• Maintain records and documentation.
• Support internal and external audits.
• Stay updated on industry standards and regulations.

Kenntnisse

Quality Assurance

IQOQPQ protocols

Regulatory knowledge

Audits

Documentation

Ausbildung

Master's in Biotechnology

Jobbeschreibung

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.

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.

Tasks

• Reviewing and approving IQOQPQ protocols and reports for a wide range of QC/Production equipments and utilities
• Ensuring compliance with relevant regulations (e.g., GMP, USP, Ph. Eur.).
• Providing technical guidance and support to project teams.
• Participating in equipment qualification meetings and reviews
• Maintaining accurate records and documentation.
• Supporting internal and external audits.
• Staying abreast of relevant industry standards and regulations.

Requirements

• Master's degree in Biotechnology or a related field
• 3 years minimum experience in QA for qualification for pharma, biotech or medtech companies
• Fluent in English
• Swiss or EU nationality