QA qualification engineer

agap2 Switzerland; Basel; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

agap2 is a European engineering and operational consulting group. We are seeking a QA professional with a Master’s in Biotechnology to support pharma, biotech or medtech clients in Basel on site.

The role requires at least 3 years of QA experience, fluent English, and eligibility to work in Switzerland or the EU. You will review IQOQPQ protocols, ensure GMP/regulatory compliance, and contribute to audits and documentation.

Qualifikationen

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

Aufgaben

• Review IQOQPQ protocols and reports for QC/Production equipment and utilities.
• Ensure compliance with GMP, USP, Ph. Eur.
• Provide technical guidance to project teams.
• Participate in equipment qualification meetings and reviews.
• Maintain accurate records and documentation.
• Support internal and external audits.
• Stay abreast of industry standards and regulations.

Kenntnisse

Fluent English

Ausbildung

Master's degree 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.

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