Job Type: Perm
Job ID: JO-2002-22127
Consultant: Karen McHugh
Are you a QC Analyst with experience working on projects related to Equipment, lab utilities and testing procedures as required by GMP?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
Senior Quality Control Analyst - Biotech - Cork
Our Client is a leading international biotech company and the role will be based in their Cork manufacturing plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This position is responsible for carrying out tasks and projects related to Equipment, lab utilities and testing procedures as required by GMP.
You will Partner with other Departments to ensure that all QC testing activities are completed in an efficient manner.
Strive to become competent in lab methods and procedures.
Train other QC analysts in the laboratory when required.
Perform analytical testing in relation to method validation and technical transfer activities to ensure all methods meet ICH, USP and EP guidelines.
Work across validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
Write, execute, report on and review IQ/OQ and PQ protocols to detail that all relevant equipment is qualified for cGMP use.
Perform routine and non-routine analytical testing activities.
Review and approve laboratory test results.
Ensure that testing and results approval are completed within agreed turnaround times.
Write and review laboratory TMs, SOPs and WIs as directed by company policy.
Strive to ensure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
You will be a valued member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Manager.
Deputizes for the QC Team Leader as appropriate.
Maintains and develops knowledge of analytical technology as well as cGMP standards.
Key Individual Contributor Competencies
Builds strong productive relationships.
Demonstrates commitment to work with teams and individuals
Asserts personal ideas and opinions using persuasion to influence others
Seeks opportunities to grow and develop professionally
Uses standard methodologies to improve business operations
Holds self-accountable for compliant and precise execution
Takes personal responsibility for decisions that successfully build customer value
Effectively handles and adapts to change
Demonstrates the courage to standalone 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
A third level qualification of a scientific/technical discipline.
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Karen McHugh is the consultant managing this position.
If you are a Senior Quality Control Analyst interested in roles based in Cork, you can contact Karen by e-mail firstname.lastname@example.org or phone +353-1-7978720 for a confidential chat.
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