QC Instrumentation Specialist

7 days ago

Dublin, Dublin City, Ireland Cpl Resources Full time

Position: QC Instrumentation Analyst Location: Swords, Co. Dublin Contract: 12-Month Fixed Term About Us SK pharmteco is a global Contract Development and Manufacturing Organization (CDMO) with state-of-the-art facilities in Korea, the 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, has been a leader for over 60 years in the development, scale-up, and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates. With our talented workforce, advanced technical capabilities, and top-class facilities, we have helped produce some of the worlds most important medicines and continue to do so today. Learn more: Current Opportunity We are seeking to recruit a QC Instrumentation Analyst for a 12-month contract to join our Instrumentation Group within the QC Department. Reporting to: QC Team Lead The successful candidate will be responsible for managing and controlling the laboratory instrumentation calibration program as well as handling unplanned maintenance activities. Key Responsibilities Coordinate the calibration schedule in collaboration with vendors (e.g., Agilent). Review calibration and qualification documentation for all laboratory instruments. Review reports related to unplanned maintenance and corrective actions. Manage changes to instruments, including relocations and decommissioning. Troubleshoot laboratory equipment and resolve technical issues. Oversee the purchase and qualification of new laboratory instruments. Manage instrument change controls to maintain compliance. Develop new SOPs and ensure all equipment-related procedures are up to date. Lead calibration investigations and implement improvements. Support the implementation, qualification, and routine maintenance of analytical instruments. Ensure GMP compliance in all QC operations and documentation. Manage relationships with suppliers, including new equipment and software solutions. Foster a culture of growth, enablement, and high performance within the team. Requirements Bachelors degree in Analytical Science, Chemistry, or a related field. Minimum of 3 years of experience in the pharmaceutical industry. Strong understanding of Quality Control operations. Experience participating in regulatory audits with knowledge of FDA regulations, GMP standards, and their application to API manufacturing. Knowledge of equipment validation and change control procedures (desirable). Strong organizational and time management skills to manage multiple tasks, prioritize workloads, and meet deadlines for calibrations, maintenance, and testing. Ability to interact effectively with Quality Assurance (QA), Instrumentation Management (IM), and multiple vendors. Highly motivated team player with proven success in collaborative environments. Skills: HPLC GC Karl Fischer

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