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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