A leading global biopharmaceutical company dedicated to supporting customers and their businesses in ever better ways. This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices, and a range of services. Selling in over 100+ countries with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. They are currently looking for a Quality Control Analyst to join their operation on a permanent basis.
- The QC Analyst reports to the Site Quality Control Lead and will be responsible for all QC test activities including but not limited to testing of Incoming materials, In Process Materials, Intermediate, API and Stability Samples, Method Transfer and Validation and Data Review.
- Development, Validation and Transfer of Analytical Methods, including cleaning method validation and associated troubleshooting as required.
- Analytical support to include monitoring of production and analytical results throughout the technology transfer and process validation phases.
- Preparation and review of laboratory documentation (e.g. Method Transfer and Validation protocols and reports, SOP's, calibration procedures, Analytical Test Records and miscellaneous protocols).
- Testing of Raw Material, Intermediates, API's and materials associated with the reaction process and cleaning process in accordance with approved procedures including the stability testing program.
- Testing of Swab and Rinse samples and visual inspection of equipment after cleaning.
- Sampling and testing of support utilities (Water, Nitrogen, Steam, Environmental Monitoring).
- Review and accuracy check of Analytical Data.
- Active participation in laboratory tier meetings.
- Active participation in problem solving, troubleshooting, laboratory investigations, compliance related activities, audit observations, continuous improvement activities and Lean Six Sigma/Operational Excellence activities.
- Participation in instrumentation calibration & maintenance. Responsible to assure that laboratory equipment is maintained and functioning properly according to specifications.
- Laboratory system support (e.g. maintain reference standards, retention samples, vendor certification, training system, HPLC & GC columns, co-ordinate evacuations, shower checks, self-inspections, Quality and Safety inspections).
- Performing data trending.
- Record and update laboratory metrics.
- Bachelor of Science in Chemistry with +2 years of quality control and analytical laboratory experience and proven experience in an analytical laboratory.
- Method Validation, HPLC and GC proficiency essential.
- Recognised LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable.
To learn more about this role apply online or contact Deanna Healy on + 353 1 6321835 for a confidential discussion.