LSC are seeking a QC Analyst for a exciting opportunity in a leading Bio-Pharmaceutical company based in Cork.
Excellent opportunity for a QC Analyst with responsibility for:
o Carrying out tasks and projects related to equipment, lab utilities and testing procedures as required by Good Manufacturing Practice (GMP).
o Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.
The QC Analyst will be responsible for:
o Achieves competency in laboratory methods and procedures.
o Trains other QC analysts in laboratory methods and procedures when required.
o Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
o Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
o Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
o Performs routine and non-routine analytical testing activities.
o Review and approval (where appropriate) of laboratory test results.
o Ensures that testing and results approval are completed within agreed turnaround times.
o Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
o Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
The QC Analyst requires:
o A third level qualification of a scientific/technical discipline is required.
o Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
o Builds strong productive relationships.
o Demonstrates ability to work with teams and individuals.
o Asserts personal ideas and opinions using persuasion to influence others.
o Seeks opportunities to grow and develop professionally.
o Uses best practices to improve business operations.
o Holds self-accountable for compliant and flawless execution.
o Takes personal responsibility for decisions that successfully build customer value.
Call Mairead in LSC 021 4777 329 for more details on this new QC Analyst role or apply directly via this advert.