Senior QA Specialist Instrument Qualification

Job description:

On behalf of our client, we are seeking a QA Expert / Senior QA Specialist Instrument Qualification in Basel to ensure GMP-compliant qualification of equipment, instruments, and systems.

About the customer:

The client is a leader in the Pharmaceutical industry, renowned for its innovative solutions and commitment to quality in healthcare.

Requirements:

• Oversee and maintain the Equipment Qualification System within DPS.
• Ensure proper qualification of equipment/instruments/computerized systems in adherence to VMP(s) and GMP requirements.
• Act as the primary QA contact for equipment qualification, maintenance, and document lifecycle management, including approval of instrument SOPs, qualification protocols, and reports.
• Serve as the main point of contact for compliance issues related to shared global systems such as LIMS, DMS, SAP, and Trackwise.
• Supervise and execute compliance activities, including GMP status tracking, trending of equipment qualification/re-qualification, and addressing supplier qualifications, changes, non-conformities, and CAPAs.
• Ensure adherence to quality agreements and resolution of audit observations for equipment suppliers and services.
• Track GMP status of equipment/instruments/computerized systems and ensure continuous compliance.
• Perform additional duties as assigned.

Competences:

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or a related discipline).
• Experience in equipment qualification and maintenance within a GMP-regulated environment.
• Familiarity with global compliance systems such as LIMS, SAP, Trackwise, and DMS.
• Strong organizational skills with the ability to handle multiple compliance activities.
• Fluent in English (mandatory); additional languages are a plus.

Compensation benefits:

• An opportunity to contribute to ensuring the quality and compliance of critical systems within a leading healthcare organization.
• A collaborative and innovative work environment.
• Opportunities for career development and professional growth.