Job Description
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, so 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.
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
Supporting an environment of continuous improvement in this area 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.
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 cGMP environment
Experience leading or participation in project-based initiatives
Flexibility is essential (willingness to work additional hours orweekends as required by business needs)
Demonstrate PC skills Microsoft Word and Microsoft Excel
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