QA Qualification Engineer — Pharma/MedTech Compliance Lead

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 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.