Job Description
My client a leading Pharmaceutical company now require a Quality Control Analyst to join their expanding team.
The Quality Control Analyst has an important role to play in the start-up of a state of the art Quality Control laboratory in a new manufacturing facility and the routine operation of the QC laboratory when start-up is complete.
This is an initial 10 month contract position based in Dublin and comes with a strong salary and benefits package. There is an excellent chance of been made permanent.
Responsibilities of Quality Control Analyst
- Contribute effectively to the design and implementation of quality systems in the QC laboratory to meet the requirements of ICH Q7A.
- 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.
- Equipment Calibration and Maintenance
- Reference Standard Management
- LIMS data management and maintenance
- Provide expertise in a variety of analytical test procedures.
- Carry out sampling and analytical testing of raw materials, packaging materials, intermediates, Drug Substance and Drug Products according to approved procedures and plant schedules.
- Carry out sampling and testing of manufacturing facility cleaning samples
- Carry out sampling and chemical testing of manufacturing facility pure water samples
- Ensure that all testing information is recorded accurately and completely according to procedures.
- Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Senior/ 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.
- Familiarity with CDS and LIMS is desirable but not essential
- 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
- 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 DS/DP facility, desirable but not essential
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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