Our client, a medical device company in Cork are currently looking to recruit a QC Analyst for their site.
What will I be doing
- 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
- 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
- Writes, executes, reports and reviews IQ/OQ and PQ protocols
- Performs routine and non-routine analytical testing activities.
- Review and approval 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.
- Provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.
- Deals with non-conformances/ and deviations
- Maintains and develops knowledge of analytical technology as well as cGMP standards.
- In process control testing and activities to support the production units.
What do I need
- 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
- Seeks opportunities to grow and develop professionally
- Holds self-accountable for compliant and flawless execution
- Takes personal responsibility for decisions that successfully build customer value
- Listens effectively
- Works effectively with people that have diverse styles, talents and ideas
- Maintains the highest standards of ethical behavior
For further information on this QC Analyst role in Cork please contact Jenny Dore on 0860449371 / firstname.lastname@example.org
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