- Receive notification of all potential Quality Incidents and Technical Queries via the CAPA management system.
- Review details in the CAPA management system. Assess how the incident has been reported and confirm that the criticality assigned is appropriate. If insufficient information is available, liaise with the individual responsible for reporting the incident and glean the necessary information to appropriately categorise.
- Raise the incident reference within the CAPA management system, ensuring the relevant departments are notified. If the incident relates to another site or business unit, follow the relevant SOP.
- If an incident is classified as critical, arrange for a critical call meeting to be held in accordance with procedure.
- Monitor the status of all QIs and TQs. Distribute a report at least weekly to notify responsible Quality Management and the QPs of all investigation response timelines, CAPA and Follow up commitments. Highlight those investigations that may affect the release of a batch document and ensure such is prioritised.
- Perform the role of Quality Point Person for critical investigations as required. Provide guidance regarding the direction or scope of an investigation, if necessary. Apply investigation and problem solving skills while maintaining a positive attitude towards those departments involved.
- Bachelor’s Degree in a life science
- Previous experience within a Pharmaceutical environment
- Experience in QMS
This position offers an excellent salary and the chance to work in a highly motivated, versatile, interesting and exciting environment.
To discuss further contact Seamus on 02890725625, if you CV isn’t up to date we can work on that.