Job ID: JOB-11655
Chemist (QC) I
My client is a Dublin-based Pharmaceutical company with sites around the world! There is a new permanent position available for a QC Chemist who will join a well-established team.
In this role, you will be responsible for conducting raw material, in process, finished product, and where applicable stability testing. You will have the opportunity to identify and troubleshoot issues related to laboratory testing and equipment so you will have to have an in-depth knowledge of scientific methods and techniques.
- You will conduct chemical and physical laboratory tests and analyze raw materials, intermediates and final product to ensure compliance with standards.
- Complete all testing, including special project / protocol testing in a timely manner that supports established production targets and SLAs.
- Maintain data integrity and ensure compliance with FDA, GLP, QSR and cGMP regulations, as well as with company SOPs and specifications.
- Observe established escalation process for laboratory issues that impact established production-related Service Level Agreements (SLAs) and/or the fulfillment of production goals.
- Participate in deviation investigations.
- Author documents that ensure cGMP compliance, such as laboratory investigation, deviations, change controls, change notices, analytical test methods; analytical test method development reports; method validation protocols; method transfer protocols and reports; method verifications protocols and reports; and instrumentation qualification documentation (URS/IQ/OQ/PQ).
- Seek process innovation and continuous process improvement and perform quality improvement initiatives in the laboratory to meet site production goals.
- Support and adhere to established processes and productivity targets while recognizing and reporting any issues or deviations from accepted standards to your supervisor
- Provide status updates on own activities and productivity challenges according to defined procedures
- A third level qualification in Chemistry or related Science, preferably a Bachelor’s Degree
- 12 – 18 months experience in relevant Quality Control experience
- Experience in pharmaceutical manufacturing facility.
- Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
- Demonstrate competency in the operation, calibration and qualification of common analytical instrumentation e.g. HPLC, Dissolution, GC, FTIR, Electro Chemistry (DME), UV/Vis and other USP instrumental and Wet chemistry technologies used in pharmaceutical Quality Control Laboratory.
- Demonstrate strong analytical laboratory skills and laboratory troubleshooting abilities.
- Demonstrated success in making effective and persuasive presentations on complex topics to upper management.
- Experience with chromatographic software packages e.g. Empower
For more information on this role in Dublin please contact Clara Burke on 086 8168273/ firstname.lastname@example.org
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