CPL in Partnership with SK biotek Ireland is seeking to recruit a Quality Instrumentation Specialist to join the QC Department. This position is in the Instrumentation group in QC Department.
Reporting to the QC Team Lead, the successful candidate will manage and control the laboratory instrumentation calibration and unplanned maintenance programme for the QC department. The role will involve
Ø Troubleshooting laboratory equipment
Ø Review of all calibration/qualification documentation.
Ø Liaising with Agilent to co-ordinate the calibration schedule
Ø Liaising with the IM and QA department on equipment projects.
Ø Provide QC analysts with support in Vaisala, Sample Manager and Empower.
Ø Drive improvement initiatives in Sample Manager and Empower.
Ø Review all Laboratory Calibration/Qualification documentation.
Ø Review all equipment unplanned maintenance reports.
Ø Manage changes to instruments, instrument relocations and decommissioning of instruments.
Ø Manage the purchase of new instruments and related installation operation qualification reports that are required.
Ø Manage laboratory instrument change controls.
Ø Ensure equipment procedures are up to date.
Ø Conduct all instrumentation calibration investigations.
Experience of regulatory agency audits and an understanding of laboratory GMP’s FDA regulations and their application to API manufacturing. The successful candidate will be required to prepare for and participate in Regulatory and Customer audits.
Experience in Equipment Validation and the change control procedures is desirable. The successful candidate will have a strong ability to manage their own workload, and will interact with QA, IT, Supply Chain and with multiple vendors. Experience in Operational Excellence, 5s, Lean Labs, yellow belt certification and yellow belt projects is desirable.
A BSc in Analytical Science, Chemistry or a related discipline is required. A minimum of 3 years’ experience working in the pharmaceutical industry is required. The desired candidate should be highly motivated, have strong teamwork skills, with proven success of working in a team environment.