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 to equipment, 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.
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.
Qualifications and 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
Listens effectively and remains open to other’s ideas.
Works effectively with people that have diverse styles, talents and ideas
Maintains the highest standards of ethical behavior
Treats people with dignity and respect
All employees are required to comply with the requirements of the company’s Environmental Health and Safety Policy, Safety Statement, associated EHS Procedures and local legislation.
Take reasonable care to protect his or her own and the safety of their 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.firstname.lastname@example.org or call 0214297900
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