QA Qualification Engineer - Pharma & Biotech QC Expert

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 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.