QA Expert

vor 9 Stunden


Basel, Schweiz Proclinical Group Vollzeit

Proclinical is seeking a QA Expert / Senior QA Specialist Instrument Qualification to join the team in Basel. The successful candidate will focus on establishing and maintaining the Equipment Qualification System. This position requires a proactive approach to ensure compliance and proper qualification of equipment, instruments, and computerized systems.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

  1. Serve as the primary contact for equipment qualification and maintenance within Quality Assurance.
  2. Manage the lifecycle of equipment qualification documents, including approval of SOPs, qualification protocols, and reports.
  3. Address compliance issues related to equipment qualification in global systems such as LIMS, DMS, SAP, and Trackwise.
  4. Oversee compliance activities, including GMP status and trending of equipment qualification and re-qualification.
  5. Ensure equipment suppliers and services adhere to quality agreements and audit observations.
  6. Track the GMP status of equipment, instruments, and computerized systems.
  7. Perform additional duties as assigned.

Key Skills and Requirements:

  1. Strong understanding of equipment qualification processes.
  2. Experience with global systems like LIMS, DMS, SAP, and Trackwise.
  3. Ability to manage document lifecycle and compliance issues.
  4. Proficiency in English is mandatory.
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