Our client, a leading Pharmaceutical company currently has a requirement for an experienced QA Specialist. Reporting directly to the Quality Assurance Team Leader, the QA Specialist will play an integral role in providing day to day Quality and compliance support to the sterile manufacturing operations.
- Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
- Implement and support a batch release system in the QA function of Sterile Manufacturing.
- Support the development of GMP training packages and delivery of training
- Participate in the preparation and review of procedures and batch documentation
- Review and approval of deviation, CAPA’s, quality events and tasks
- Ensure the quality system is effectively implemented and maintained.
- Acts as Quality Point person for systems/processes providing guidance/feedback on quality issues
- Perform timely review of documentation/investigations/reports highlighting and assisting in the resolution of concerns commensurate with the risk
- Work with relevant departments to ensure timely closure of quality actions/findings
- Actively contribute to continuous improvement initiatives.
- Conduct duties in a safe manner and report all safety issues or concerns
- Bachelor’s degree in a science-related subject is essential
- 2-3 years’ experience in a manufacturing environment, sterile experience is preferable
- Effective technical knowledge of sterile manufacturing processes
- Operational experience of quality systems in a dynamic manufacturing environment
- Knowledge of requirements for cGMP, US and EU regulatory requirements
- Full understanding of relevant quality and compliance regulations
- Able to manage projects to plan/budget
- Effective facilitator
- Good communication skills at organisation, team and individual levels
- Understands KPI’s for the team and site
- Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs
- All applicants must be open to shift work
For a confidential discussion and more information on the role, please contact Josh Barnes.