QC Analyst required to join a global pharma company based in Dublin.
- 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.
- Recognize and report to immediate supervisor any issues or deviations from accepted standards.
- Provide status updates on own activities and productivity challenges according to defined procedures.
- Complete and conform to all training requirements for job role, including company-required and job role-specific training.
- Carry out and assist in the ongoing training of new and existing personnel, as appropriate.
- Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
* 6 months minimum GMP experience with 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.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.