ABOUT US
SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korean company with revenues of $99 billion in 2023. Our mission is to ‘produce and deliver life-changing therapies that improve patient outcomes and save lives’.
The SK pharmteco Small Molecule, Europe, facility located in Swords, Co. Dublin, Ireland, has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years. With a talented workforce, exceptional technical capabilities and facilities, we have made some of the world’s most important medicines and continue to do so.
Further information on SK pharmteco can be found at www.skpharmteco.com
Current Need
The QC department is seeking to recruit a QC Instrumentation Analyst for a 12-month contract position. This position is part of the Instrumentation group in the QC Department.
Position Description
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:
- Liaising with Agilent to co-ordinate the calibration schedule
- Reviewing all Laboratory Calibration/Qualification documentation
- Reviewing all equipment unplanned maintenance reports
- Managing changes to instruments, instrument relocations, and decommissioning of instruments
- Troubleshooting laboratory equipment
- Managing the purchase of new instruments and related installation operation qualification reports
- Managing laboratory instrument change controls
- Developing new procedures and ensuring equipment procedures are up to date
- Conducting all instrumentation calibration investigations
- Supporting the implementation and qualification of analytical instruments, and in their routine/periodic maintenance
- Ensuring GMP compliance of laboratory operations and documentation
- Managing equipment supplier relations for new equipment and software used in the laboratory
- Fostering and supporting a culture of growth, enablement and high performance
Minimum Requirements
- 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
- Knowledge of quality control operations
- Experience with regulatory agency audits and understanding of laboratory GMPs, FDA regulations, and their application to API manufacturing
- Ability to prepare for and participate in Regulatory and Customer audits
- Experience in Equipment Validation and change control procedures (desirable)
- Strong ability to manage workload (multiple tasks or projects), prioritize work, and ensure timelines are met for equipment calibrations, maintenance, and testing
- Ability to interact with QAS, IM, and multiple vendors
- Highly motivated, with strong teamwork skills and proven success working in a team environment