QC Drug Product Technologist

Job Description

Summary / purpose of the positionTo perform the analysis of samples in a timely manner according to approved analytical procedures. To develop analytical skills through training and diversity in techniques. Perform troubleshooting as required.Main responsibilities / job expectations
• Analysis of Drug Product batches according to approved analytical SOPs and as per relevant specification. This may include any of the following techniques (and is not limited to): Microbiological test methods such as Endotoxin and Sterility testing, ELISA, UV, Karl Fischer, pH, HPLC and Sub Visible Particulates.
• Perform activities to support the daily test schedule include media release testing and cleanroom preparation for Sterility testing.
• Training must be completed as per relevant training modules and supported with external training courses as required. The Technologist must become knowledgeable in all analytical techniques performed. Attend training in relevant Ipsen manufacturing location as required. The QC Drug Product (QC DP) Technologist must support the training of new staff and provide support to other Technologists.
• Results are compiled and submitted for review in a timely manner and it is important that attention is paid to the detail of the SOP and documentation.
• The QC DP Technologist must raise any Unplanned Events or Out of Specification results in a timely manner following discussion with Senior personnel and must inform the Senior personnel immediately of any such events. The QC DP Technologist must inform the Manager/Senior personnel of any issues as they arise, which may impact on the test and release schedule.
• Laboratory practices must promote accuracy and precision in daily laboratory routines.
• Laboratory Equipment must be calibrated in accordance with the schedule.
• Complete activities for Inspection readiness.
• Purchasing of laboratory consumables and reagents required to support testing.
• Generate SOPs, test methods, risk assessments and other documentation as required.
• Adherence to the Ipsen safety and environmental policies during analysis.
• Liaise with personnel at other Ipsen manufacturing facilities to ensure accurate transfer of information and for troubleshooting any issues as they arise.
• Co-ordination of sample and reference standard shipments to Dublin
• Knowledge sharing to ensure both sites are aligned, and procedures are harmonised.
• Integrated approach within the Laboratory, supporting EE initiatives (e.g. 5S).
• Ensure high standards of housekeeping are maintained in the area.

Keyskills :
chemistry educationdrug monitoringclinical laboratory improvement amendmentsproficiency testinglaboratory quality assurancetheoretical chemistrydrug regulatory affairs