Quality Assurance Specialist

About the role

Phargentis SA, a Swiss virtual drug development company, is expanding its Quality Assurance Department. The Quality Assurance Specialist will support the Quality Management System (QMS) and ensure compliance with pharmaceutical and medical device regulations.

Key responsibilities

• Support the management and continuous improvement of the QMS.
• Assist with change controls, deviations, CAPAs, and investigations.
• Review batch records and related documentation.
• Monitor, qualify, and evaluate suppliers according to company procedures.
• Draft, review, and maintain SOPs, work instructions, and other QMS documents.
• Deliver training on company procedures.
• Prepare, coordinate, and execute internal and external audits.
• Monitor processes to ensure compliance with GMP, GDP, ISO 13485, and MDR.

Required profile

• Master's degree in Chemistry, Biology, Pharmaceutical Chemistry and Technology, Pharmacy, Pharmacology or related scientific discipline.
• Minimum 2 years of experience in Quality Assurance or Quality Control within regulated industries (pharma, biotech, medical device).
• Native-level proficiency in Italian and English at B2 level or higher.
• Proficiency with Microsoft Office applications.

Required skills

• Basic knowledge of GMP and GDP requirements.
• Familiarity with Quality Management System (QMS) documentation.
• Understanding of ISO 13485 and the Medical Device Regulation (MDR).
• Knowledge of applicable 21 CFR requirements.
• Proficiency in Microsoft Office.