Qc Instrumentation Specialist
2 days ago
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 Korea 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 worlds most important medicines and continue to do so.
Current Need The QC department are seeking to recruit a QC Instrumentation Analyst for 12 months contract position.
This position is in the Instrumentation group in 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 Review all Laboratory Calibration/Qualification documentation.
Review all equipment unplanned maintenance reports Manage changes to instruments, instrument relocations and decommissioning of instruments.
Troubleshooting laboratory equipment Manage the purchase of new instruments and related installation operation qualification reports that are required.
Manage laboratory instrument change controls.
Develop new procedures and ensure equipment procedures are up to date Conduct all instrumentation calibration investigations.
Support the implementation and qualification of analytical instruments, and in their routine/periodic maintenance Ensure GMP Compliance of laboratory operations and documentation Managing equipment supplier relations for new equipment and software to be used in the laboratory Foster and support 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 of regulatory agency audits and an understanding of laboratory GMPs 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 (multiple tasks or projects, prioritise work, and ensure timelines are met for equipment calibrations, maintenance, and testing) and will interact with QAS, IM and with multiple vendors.
The desired candidate should be highly motivated, have strong teamwork skills, with proven success of working in a team environment.
Skills: GMP API manufacturing instrument calibration
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