QA qualification engineer

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

Zusammenfassung

agap2 is a European engineering and operational consulting group with a focus on Pharma, Biotechnology, Medical Devices, and more. We seek a QA Consultant to support client projects on site in Basel, bringing expertise in IQOQPQ and regulatory compliance while adapting to diverse environments across large-scale projects.

The role emphasizes QA qualifications, regulatory knowledge (GMP/USP/Ph. Eur.), and collaboration with project teams to deliver accurate documentation and successful audits.

Qualifikationen

• Master's degree in biotechnology or related field.
• 3 years minimum experience in QA for qualification in pharma/biotech/medtech.
• Fluent in English.
• Swiss or EU nationality.

Aufgaben

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

Kenntnisse

Quality Assurance

IQOQPQ protocols

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