QC Analyst - East Cork

Pe Global

Cork

PE Global is currently recruiting for a QC Analyst for a Client site in Cork: This position is responsible for carrying out tasks and projects related toequipment, lab utilities and testing procedures as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner. General Responsibilities Achieves competency in laboratory methods and procedures. Trains other QC analysts in laboratory methods and procedureswhen required. Performs analytical testing activities in relation to methodvalidation and technical transfer activities to ensure that allmethods meet ICH, USP and EP guidelines. Executes validation, operation, maintenance, calibration andtroubleshooting of equipment and its associated software. Writes, executes, reports and reviews IQ/OQ and PQ protocols toensure that all relevant equipment is qualified for cGMP use. Performs routine and non-routine analytical testing activities. Review and approval (where appropriate) of laboratory testresults. Ensures that testing and results approval are completed withinagreed turnaround times. Writes and reviews laboratory TMs, SOPs and WIs as directed bycompany policy. Ensures QC activities are carried out in compliance with productlicense commitments, cGMP and company quality standards. Is an active member of the QC group and provide assistance withother group activities as required and communicates relevantissues to the QC Team Leader and Manager. Deals with non-conformances/ deviations in an accurate andtimely manner. Deputizes for the QC Team Leader as appropriate. Maintains and develops knowledge of analytical technology aswell as cGMP standards. In process control testing and activities to support the productionunits. Qualifications and experience A third level qualification of a scientific/technical discipline isrequired. Knowledgeable of FDA/EMEA regulatory requirements applicableto biologics and/or pharmaceuticals. Builds strong productive relationships. Demonstrates ability to work with teams and individuals. Asserts personal ideas and opinions using persuasion toinfluence others. Seeks opportunities to grow and develop professionally. Uses best practices to improve business operations. Holds self-accountable for compliant and flawless execution. Takes personal responsibility for decisions that successfully buildcustomer value. Effectively manages and adapts to change. Demonstrates the courage to stand alone on ideas and opinionsthat differ from others. Listens effectively and remains open to other’s ideas. Works effectively with people that have diverse styles, talents andideas. Maintains the highest standards of ethical behavior. Treats people with dignity and respect. All employees are required to comply with the requirements of thecompany’s Environmental Health and Safety Policy, SafetyStatement, associated EHS Procedures and local legislation. Take reasonable care to protect his or her own and the safety oftheir colleagues who may be affected by their actions. Comply with EHS rules and procedures always. Understand the potential EHS impact of their activities. Attend and participate in EHS training as required. Use PPE and safety equipment as required. Report all incidents, accidents, and near miss events. Report unsafe plant, equipment, acts, procedures or issues. Make suggestions to improve health and safety in the workplace. Actively participate in work area EHS teams. Not turn a ‘blind eye’ to unsafe acts or situations. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

2228 days ago