QC Equipment Validation Specialist - Dublin, Ireland - Westbourne IT Global Services

Description

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 or weekends as required by business needs)

Demonstrate PC skills Microsoft Word and Microsoft Excel