Job Description:
This resource will be expected to lead the implementation process for new laboratory equipment installations within the analytical teams of QC and Analytical R&D (AR&D), utilising support from other departments such as QA, IT and analytical as required. The candidate needs to have specific knowledge of the end-to-end equipment installation and qualification process for analytical instrumentation in a cGMP environment.
Duties & Responsibilities:Ensure QC equipment is validated to comply with all current regulatory data integrity requirements.Ensure that the deliverables of each assigned task are dealt within the time frames defined, with quality and according to cGMP.Perform initial validation of QC Laboratory equipment and instrumentation.Perform re-validation of the instrumentation on a regular basis.Ensure that analytical equipment is qualified, calibrated and maintained.Conduct PM/Cal, corrective maintenance (CM) and periodic review of all laboratory equipment.Support Team Lead and Lab Analysts for the day-to-day running of the laboratory.Ensure safe practices are adhered to at all times in the laboratory.Provide training and support to QC laboratory colleagues.Provide technical assistance in the areas of trouble shooting and investigations.Support an environment of continuous improvement by identifying and implementing practices to deliver efficiency, cost reduction, quality and service level improvements.Qualifications:University, or equivalent, degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or in similar Chemistry/ Health Sciences fields.1 - 3 years' experience in pharmaceutical QC environment or equivalent.Experience working in an HPRA/FDA regulated environment is essential.Previous experience in equipment qualification/calibration activities.Knowledge and hands-on experience in Analytical Chemistry, and QC procedures.Strong communication skills.Result driven, team player, able to deal with multiple projects/tasks.Demonstrated problem solving, initiative and decision-making skills.Knowledge and experience in a cGMP environment.Experience leading or participating in project-based initiatives.Flexibility is essential (willingness to work additional hours or weekends as required by business needs).Demonstrate PC skills in Microsoft Word and Microsoft Excel.
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