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.