
Quality Assurance Specialist
2 weeks ago
The role of Quality Assurance Associate is crucial in supporting the development and maintenance of a Pharmaceutical Quality System.
- Supporting daily operations of change control processes
- Generating and sharing Change Control performance metrics
- Managing key elements of quality systems: document management, supplier management, product dispositions, deviations, CAPA, and contributing to quality reviews
Key Responsibilities:
- Support the daily processing of Change Control
- Provide feedback on partner approvals and expected dates
- Ensure necessary information is provided to partners
- Manage the change control tracker daily
- Organise weekly meetings and ad hoc meetings as needed
- Update and communicate Change Control performance metrics
- Support product quality complaint processing
- Approve pre-approved documents when required
- Process documents through an eQMS and support eQMS administration
- Generate performance metrics and support quality projects as needed
- Document handovers during personnel changes or responsibility transitions
Requirements and Skills:
- 1-2 years of QMS administration experience, preferably in change control, complaints, or documentation control
- Diploma or degree in a science-based subject
- Strong organisational and communication skills
- Excellent interpersonal skills and ability to work in a dynamic environment
- Experience working with cross-functional teams
- Proficiency in Excel and PowerPoint
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