QC Analyst

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Achieves competency in laboratory methods and procedures.
• Trains other QC analysts in laboratory methods and procedures
• when required.
• Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
• Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
• Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
• Performs routine and non-routine analytical testing activities.
• Review and approval (where appropriate) of laboratory test results.
• Ensures that testing and results approval are completed within agreed turnaround times.
• Writes and reviews laboratory TMs, SOPs and WIs 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 and Manager.
• Deals with non-conformances/ deviations in an accurate and timely manner.
• Deputizes for the QC Team Leader as appropriate.
• Maintains and develops knowledge of analytical technology as well as cGMP standards.
• In process control testing and activities to support the production units.

Education & Experience

• A third level qualification of a scientific/technical discipline is required.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Builds strong productive relationships.
• Demonstrates ability to work with teams and individuals
• Asserts personal ideas and opinions using persuasion to influence 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 build customer value
• Effectively manages and adapts to change
• Demonstrates the courage to stand alone on ideas and opinions that differ from others.