Job Description
My client a leading Pharmaceutical company now require a Quality Control Analyst – Cell Therapy to join their expanding team.
The QC Analyst has an important role to play in the start- up of the laboratory in a new Biologics manufacturing facility and the routine operation of the QC laboratory when start-up is complete.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Quality Control Analyst – Cell Therapy
- Contribute effectively to the design and implementation of quality systems in the QC laboratory.
- Work with other QC personnel in the preparation and review of the required documentation in the QC laboratory, including Standard Operating Procedures, Analytical Procedures, Analytical Worksheets and Material Specifications.
- Participate, as directed, in the following activities in the QC laboratory:
- Equipment Calibration and Maintenance
- Provide expertise in a variety of analytical test procedures and equipment.
- Carry out sampling and analytical testing of raw materials, packaging materials, intermediates, Drug Substance and Drug Products according to approved company procedures and plant schedules.
- Ensure that all testing information is recorded accurately and completed according to company procedures.
- Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Senior Analyst/ QC Executive so that corrective action may be taken.
- Provide assistance and guidance in deviation investigations, OOS investigations, and change proposals.
- Provide samples to contract testing laboratories and liaise with these laboratories as required.
- A minimum of 2 years’ work experience in a regulated GMP/GLP environment
- Practical experience with HPLC systems and troubleshooting
- Practical experience in cell counting, morphology and flow cytometry is desirable
- Experience with writing SOP’s / validation protocols
- Experience with Method transfer / validation/verification, desirable but not essential
- Experience working in a Biologics facility, desirable but not essential
- Familiarity with CDS and LIMS is desirable but not essential
The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below