Quality Assurance Representative
Posted on Apr 16, 2019 by Anonymous
The successful QA Rep Engineering will have a BSc (Hons) Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline with ideally a minimum of 2 years similar QA experience.
- Quality oversight of and guidance to a Biotech project
- Maintenance of all aspects of GMP compliance for the area(s) of responsibility
- Establishment, maintenance and management of a control system for the specific Quality System(s)/Program
- Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program
- Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program
- Review and approval of change controls and failure investigations, associated with the area(s) of responsibility
- Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
- Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, GMP utilities and periodic quality evaluations.
- Review and approval of other key GMP documents such as GMP standard operating procedures, specifications, process flow diagrams as appropriate to area of responsibility
- Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in area of responsibility
- Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility
Vivid Resourcing Ltd