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Quality Assurance Specialist
2 months ago
- Provide day-to-day support for commercial quality assurance activities.
- Assist in maintaining quality systems, including deviations, exception reporting, change control, supply agreements, document control, and quality metrics reporting.
- Complete scheduled records and quality system tasks in compliance with internal standards and EU GMP.
- Participate in Quality Risk Management (QRM) assessments.
- Compile and review product quality review sets for completeness and compliance with EU GMP, internal requirements, and regulatory dossier submissions.
- Hold a degree in a relevant scientific subject or have equivalent working experience.
- Previous working experience in a quality-based role, preferably in the pharmaceutical or manufacturing industry.
- Good knowledge of GMP environments.
- Basic experience in quality administered systems. Previous use of TrackWise QMS is beneficial.
