Our client is a leader in discovering and delivering innovative medicines solving serious health issues worldwide and addressing medical challenges of the future. They are an Equal Employment Opportunity Employer and are passionate about bringing together individuals from diverse backgrounds to develop innovative health solutions. Are you ready to join a high performing, ambitious team and be part of an inclusive work environment? This may be the career for you…..
This client is based in Dublin and are looking to hire a number of QC Chemists to join their team. The ideal candidates will have a minimum of 12 months of experience in a relevant QC role in a pharmaceutical manufacturing facility.
- 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
- 2 years relevant Quality Control experience or equivalent combination of education and experience (3-5 years).
- 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
What's in it for you?
- Competitive package
- Life assurance
- Excellent company culture
- Excellent opportunity to develop experience and career in a multinational pharma company
For a confidential discussion and more information on the role, please contact Niamh Cregg