The QC Analytical Analyst will be responsible for all QC test activities including testing of Incoming materials, In-Process Materials, Intermediate, API and Stability Sample, Method Transfer and Validation and Data Review.
The role will maintain the Quality System for QC; ensuring that Standard Operating and Analytical Procedures are in place, adhered to and that compliance with cGMP is maintained through ongoing training and process review.
The QC Analyst role must demonstrate flexibility in relation to types of work, shift patterns
You will report to Site Quality Control Lead
- 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 through to commercial manufacturing.
- Preparation & 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.
- Performing Own Training activities (reading acknowledgments, attendance at training events, online training completion).
- 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, stability testing, 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.
- Immediately notify any issues to the QC Head and support subsequent investigations.
- Responsible for ensuring that they understand and comply with all cGMP's associated with their job.
EDUCATION AND EXPERIENCE
- Bachelor of Science in Chemistry with 5-10 years of proven quality control and analytical laboratory experience.
- Method Validation, HPLC and GC proficiency essential
- Recognised LSS Qualification (Yellow Belt, Green Belt, Black Belt) desirable
For further information on this QC Analytical Analyst position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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