Purpose Statement Purpose Statement To provide technical/calibration support to the PQS (Pharmaceutical Quality System) at our clients site in Cork.
Key Responsibilities Key Responsibilities To review develop local site governing calibration procedure for the Pharmaceutical Quality System.
To develop PQS doing procedure template to allow development of equipment calibration procedures within the PQS process.
Maintain the Calibration Management System for PQS.
Create maintain calibration work orders.
Track trend equipment due overdue.
Serve as a point of contact for PQS for the calibration function to represent the calibration department with the value stream, compliance Quality.
Engage with the value stream as necessary on calibration relation requirements.
Creates maintains calibration records, logs files.
Prepares, maintains distributes calibration reports/metrics.
Gathers prepare data in preparation for project needs.
Provides input to Equipment Suitability Selection as needed from a Calibration management perspective.
Implements staffing plans to meet the needs of the value stream.
Develops work schedules for Calibration technicians by assessing priorities, workload resource management.
Leads by example by observing complying with all safety rules quality regulations.
Troubleshoots solves problems requiring interpretation of procedures practices.
Creates or updates documentation as needed to resolve issues.
Creates or modifies equipment, schedule, work records within the calibration management system.
Applies knowledge of technical concepts.
From basic to complex, towards the resolution of manufacturing /of research development calibration tasks.
Support team members in the trouble shooting problem solving where interpretation of procedures practices is necessary.
Analyses situations or data to identify issues trends.
Collects, complies, measures, organises records data.
Provides input to engineering, qualifications validations studies reports.
SME for calibration in internal external quality audits support in same in the role as audit facing SME for the site.
Qualifications and Experience Good technical writing skills.
Development of site SOP's Equipment Calibration Procedures.
Good communication skills (Reporting on Monthly Metrics/Representing in Audits).
Influencing Negotiating (Vendor Internal Customers).
Candidate will need 3-5 years relevant experience in a calibration engineering role with experience in the Pharma sector.
Qualification Requirements - Level 8 in Physics/Instrumentation/Controls or equivalent technical qualification.