Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Manages to complete all calibration and instrumentation repair activities according to schedule to minimize impact to manufacturing.

Manages team of Supervisors and Calibration Technicians including technical development, setting of goals and performance expectations, and succession planning.

Implements continuous improvement projects to increase efficiency of site calibration program including optimizing calibration tolerances and frequencies, implementing new calibration standards, assessing inhouse vs outsourced calibrations, streamlining calibration procedures, and performing criticality assessments.

Benchmarks with other sites and organizations to ensure calibration program is implementing the latest best practices and innovative technologies.

Manages annual budget and forecasting for the calibration area and identifies cost savings across the team.

Owns investigations for calibration Out of Tolerances and Quality Notifications and ensures corrective and preventive actions are implemented ontime to prevent reoccurrence of events.

Owns the site Asset Lifecycle Management Plan for calibrated instruments and prioritizes capital investments to upgrade instrumentation.

Delivers timely resolution of all technical issues and investigations for calibration Out of Tolerances and Quality Notifications for onsite calibrated instruments and systems.

Manages investigations for process deviations, technical assessment of issues, root cause investigations, CAPA task management.

Utilizes SAP and Maximo CMMS to review calibration technician work orders and generates reports for investigations and metrics development.

Designs calibration strategy for new and existing instruments, defining accuracy tolerances and determiningrevising calibration intervals.

Owns the Temperature Monitoring System, including managing of system upgrades and validation projects.

Lead representative for any audit queries related to calibration area.

Investigates innovative technologies and methods in the calibration area and leads projects to implement at the site.

Owns data integrity initiative for calibrated instruments to ensure compliance with standards and regulations.

Analyses monthly team metrics, ongoing calibration program improvement projects, and compliance topics and presents data to upper management.

Identifies and implements cost reductions by eliminating nonvalueadded work and reducing external calibration service purchase order costs.

Stays informed of industry best practices and innovative technologies, attends metrology conferences, and events, and implements standards across the site. Monitoring and evaluating drug safety data

Ensuring regulatory compliance with global health authorities e.g., FDA, EMA

Managing adverse event reporting systems

Leading audits and inspections related to pharmacovigilance

Overseeing signal detection, risk management plans, and safety data exchange agreements