My client a leading Pharmaceutical company now require a QC Analyst to join their expanding team.
The Quality Control Analyst will contribute effectively to the design and implementation of quality systems in the QC laboratory. They will collaborate 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.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Quality Control Analyst
- Provide expertise in a variety of analytical test procedures.
- Carry out sampling and analytical testing of raw materials, packaging materials, intermediates and finished API product according to approved company GC procedures and plant schedules.
- Ensure that all testing information is recorded accurately and completely according to cGMP 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, change proposals and batch disposition.
- Carry out status labelling of materials as required.
- Provide samples to contract testing laboratories and liaise with these laboratories as required.
- Carry out method transfer and method validation work as required, to meet project deadlines.
- Review equipment qualification documentation for QC Laboratory equipment.
Requirements of Quality Control Analyst:
- Minimum of a BSc Degree (life science)
- A minimum of 3 years' work experience in a regulated GMP/GLP environment.
- Practical experience with HPLC and GC systems.
- Experience with writing and reviewing SOP's / validation protocols.
- Experience with Method transfer / validation, desirable but not essential.
- Experience working in an API facility, desirable but not essential.
- Must be flexible to work on a 24/7 facility, high shift allowance will be paid
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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