My client a leading Pharmaceutical company now require a QC Analyst - Biologics to join their expanding team.
The QC Analyst - Biologics 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 QC Analyst - Biologics
- 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.
- Carry out method transfer and method validation/verification work as required, to meet project deadlines.
- Review equipment qualification documentation for QC Laboratory equipment.
- Ensure timely completion of all SOP, reading, training and assessments.
- 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 essentia
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