Our client, a medical device company in Clonmel are currently looking to recruit a Quality Engineer to cover a maternity leave contract.
- Working within the on-site Laboratory you will support new process/product introductions and process improvement requirements through writing, executing and review of IQ/OQ/PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
- Design and develop validation documentation to support new process introduction.
- Execute validation studies.
- Implement and co-ordinate the change control process while ensuring the timely approval of change documentation.
- Conduct data analysis to evaluate process capabilities and make recommendations for process improvements where necessary.
- Investigate and trouble-shoot instrumentation issues which occur and determine solutions.
- Assist in audit preparation for lab equipment for internal and regulatory audits
- Drive continuous improvement in lab operations through labs LBP.
- Support the Company Programs and culture
- Perform laboratory duties and other required support functions to support department objectives.
Qualifications & Experience:
- Degree in a Science / Engineering discipline or equivalent.
- A proven track record in development or support of validation programs in areas of equipment and laboratory equipment.
- Knowledge of laboratory processes for equipment calibration and validation.
- Previous experience in qualification and validation of computerised systems would be a distinct advantage.
- Strong analytical and associated problem-solving skills.
- Excellent track record in safety compliance.
- The successful candidate must demonstrate excellent written and verbal communication skills and have the ability to work in a team based collaborative environment
For further information on this Quality Engineer role in Clonmel please contact Orla Crowley Healy on 086 0449473 / firstname.lastname@example.org
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