QA qualification engineer

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

Zusammenfassung

agap2 Switzerland is seeking a QA professional to support qualification activities for pharma, biotech, and medtech projects on site in Basel. The role focuses on reviewing IQOQPQ protocols, ensuring GMP/USP/Ph. Eur.

compliance, and guiding project teams with technical QA expertise. The ideal candidate holds a Master’s degree in Biotechnology, has at least three years of QA experience in relevant industries, and is fluent in English.

Qualifikationen

• 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.

Aufgaben

• Reviewing and approving IQOQPQ protocols and reports for a wide range of QC/Production equipment 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.

Kenntnisse

Quality Assurance

Documentation

Auditing

Regulatory compliance

QA processes

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