Senior Quality Assurance Specialist for Laboratory Equipment
This is an excellent opportunity to join a leading multinational organization in Dublin. The Senior QC Associate will be responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems in a cGMP Quality Control environment.
Key Responsibilities:
1. Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring schedules are adhered to.
2. Reviewing and filing of QC calibration & maintenance documentation.
3. Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
4. Conduct periodic reviews of instrument validation as part of the validation life cycle.
5. Alerting management in the event of equipment failing to meet requirements.
6. Scheduling and coordination of equipment repairs and maintenance with vendors/contractors.
7. Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
Requirements:
* Bachelor's degree in a Science related field is required.
* Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
* Detailed knowledge of methodologies, instrumentation and analytical techniques used for biopharmaceutical testing.
* Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
Benefits:
The successful candidate will have the opportunity to work with a dynamic team in a fast-paced pharmaceutical environment.