Duties & Responsibilities

• Perform day to day supervisory activities for the calibration team, including budget oversight.
• Management of the Plant sterilization programme
• Assist with identifying emerging instruments and metrology technologies, gather requirements, evaluate the technologies, and make recommendations for new technologies which will provide potential competitive advantage in the area of measurement.
• Perform IQ/OQ/PQ’s, gauge R&R’s, correlation studies and regressions of instruments/equipment.
• Provide knowledge on the set up and operation of all metrology equipment and assist in technical guidance and fault diagnosis.
• To identify best practice procedures for instruments and metrology equipment set up and maintenance.
• Write requirements/specification in order to procure and support validation activities in line with business needs.
• Procedure and test method development.
• Carry out data analysis and investigate issues and perform follow up corrective and preventative actions.
• Identify opportunities for Cost of Quality reduction (COQ) and lead COQ initiatives for calibration.
• Ensure all instrumentation and metrology equipment is fully capable, fully documented and that operations are trained to maintain it.
• Ensure that all pharma instrumentation is calibrated in compliance with the pharma and calibration SOP’s
• Ensure all reporting and data trending commitments are met.
• Liaise with external vendors to ensure that standards are certified to B&L requirements.
• Liaise with project teams with regards new technology introduction, technology transfer & process transfer.
• Troubleshooting metrology issues and actively participate in establishing new calibration procedures for new equipment and also make recommendations for changes to existing equipment.
• Support, guidance and training for employees on instruments.
• Authoring of new and updating of current calibration SOP's and forms.
• Participate in putting systems and procedures in place to ensure GMP compliance with regard to calibration records and documentation.
• Participate in quality audits with regard to calibration, ensuring area is audit ready.
• Support the site internal audit programme
• Additional requirements of the job will be specified by the Quality Systems Development Manager

Requirements

• Third level Qualification in Science or Engineering, specific metrology qualification an advantage.
• 3 years plus experience in a supervisory position.
• Statistics/Six Sigma qualification desirable