Quality Assurance Specialist

Key Responsibilities :

• Lead and document deviations, investigations, and CAPAs within GMP-regulated environments, specifically supporting TOS functions.
• Act as the primary Quality representative for CMRs (Change Management Requests) and TrackWise investigations.
• Provide technical writing support for detailed investigations and root cause analyses (e.g., 5 Whys, Fishbone diagrams).
• Collaborate with operations to assess GMP issues and determine appropriate quality actions.
• Challenge existing processes and contribute to continuous improvement initiatives (e.g., 5S).
• Maintain and review GMP documentation related to instrumentation, equipment, and utilities.
• Support CMMS-related quality activities and ensure compliance with internal procedures.
• Help reduce the burden on managers by owning deviation workflows and TrackWise entries.

Qualifications :

Preferred Skills :