QC Instrumental Specialist

QC Equipment Specialist

Duties & Responsibilities:

- Ensure QC equipment complies with all current regulatory data integrity requirements

- Ensure that the deliverables of each assigned task are dealt within the timeframes defined, with quality and according to cGMP

- Act as part of the QC Support Team within the QC Laboratory

- 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