An exciting opportunity for an experienced Quality System Engineer to join a leading medical device/pharmaceutical company based in Cork on a permanent contract. The successful candidate will provide expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant.
- Responsible for maintenance of PQS Global Policies and Procedures (e.g., working with SMEs to ensure that reviews are completed and that where applicable harmonization is maintained between the PQS and the main BSC QMS).
- Support of the Legislation Impact Assessment Team (LIAT) in the assessment of Regulatory and GMP Rules and Guideline changes
- Management of the PQS helpdesk ensuring it is maintained and functions effectively to support stakeholders.
- Control and Maintenance of; how to use’ Mastercontrol system procedures and
- Lead the Mastercontrol training provision to Divisional PQS users when required.
- Support for maintenance of job role and training curricula within the system (e.g., assisting with updates and ensuring that scheduled reviews are completed).
- Responsible for supporting configuration and documentation of out of the box modules within the iQMS including review of qualification activities required for quarterly updates.
- Assisting with migration of data into and out of the Mastercontrol system.
- Maintaining and managing changes to the system User Requirement Specification and Trace Matrix for recording testing performed against each requirement for the iQMS.
- Responsible for the resolution of any quality system issue with the iQMS encountered during routine use (e.g., minor issue resolution and communication with Mastercontrol support to resolve any issues encountered).
- 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
- Excellent written and verbal communication skills
- Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
For a confidential discussion and more information on the role, please contact Barry O'Brien.