Job Description
Purpose StatementPurpose StatementTo provide technical/calibration support to the PQS (Pharmaceutical Quality System) at our clients site in Cork.Key Responsibilities Key ResponsibilitiesTo 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 ExperienceGood 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. #J-18808-Ljbffr