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Location: Cork
Duration: 12 months
Hours: 39 hours
This position is responsible for carrying out tasks and projects related TDS AD activities in Separation Sciences at Janssen Sciences Ireland UC (JSI) as required by Good Manufacturing Practice (GMP). Partners with other departments to ensure that all TDS AD activities are completed in an efficient manner.
Roles and Responsibilities
Achieves competency in TDS AD laboratory methods and procedures.
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. Identify trending of results as required.
Work as authorized personnel for handling of controlled substance as per laboratory procedures, where applicable.
Performs analytical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR, USP and EP guidelines as per TDS AD laboratory methods and procedures.
Escalate any non-conformances noted immediately to the TDS AD Team Lead.
Complete non-conformances / deviations in an accurate and timely manner.
Initiate Quality Issues identified, participate in the investigation, perform investigation analysis and provide necessary information to enable implementation of effective CAPA.
Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
Ensure laboratory equipment and instruments are properly maintained via execution of calibration and preventive maintenance program.
Promotes a continuous improvement culture and providing leadership in this area.
Ensure trainings are completed on time and all tasks are performed only after completion of trainings on current effective procedures.
Perform laboratory support activities as per training and perform tasks related to audit readiness.
Is an active member of the TDS AD group and provide assistance with other group activities as required and communicates relevant issues to the TDS AD Team Leader and Manager.
Maintains and develops knowledge of analytical technology as well as cGMP Standards.
How to Succeed
A third level qualification in a scientific/technical discipline required.
One years experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Demonstrated knowledge and testing experience in an FDA/IMB approved QC
Compliance with the cGMP, GMP, EHS, WWRIM, AE/PQC, IAPP and other local legal and/or regulatory requirements.
Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in biological test procedures.
Proficient in using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
Cooperate efficiently with the different partners.
Benefits
This role offers a very competitive hourly rate. xcfaprz This contract will run for 12 months.
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Sprachkenntnisse
- English
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