Scientist

Pe Global

Limerick

PE Global is currently recruiting for a Scientistfor a Client site in Limerick – POSITION SUMMARY : This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures for a project as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner. ESSENTIAL FUNCTIONS:· Achieves competency in CBIL laboratory methods and procedures. Trains other QC analysts in laboratory methods and procedures when required. Performs Chemical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR and USP guidelines. Executes testing activities as specified in IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use. Performs routine Chemical testing activities during Plant production phase. Reviews laboratory test results when required. Ensures that testing and results approval are completed within agreed turnaround times. Writes and reviews laboratory SOP’s as directed by company policy. Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards. Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader. Anticipates and plans for future requirements in the area. Deputises for the QC Team Leader as appropriate. Maintains and develops knowledge of analytical technology as well as cGMP standards. This is not an exhaustive, comprehensive listing of job functions. May be required to perform other duties, as the project requires. REQUIREMENTS: Third-level qualification (Minimum: Primary degree in a science discipline. HPLC experience and peer reviewing. At least 3 years industrial experience in the Pharmaceutical/Medical Devices Industry. Good knowledge of FDA and ISO requirements. Good organization skills and familiarity with computer packages. Interested candidates should submit an updated CV, marked for the attention of Audrey. audrey.brennan@peglobal.net or 00353 21 4297900. This job originally appeared on RecruitIreland.com.

2394 days ago