A QC analyst is required for a shift role within a Chemistry lab in West Dublin. This team supports the production of a commercial Cancer treatment drug.
The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. This brief also demands a commitment to the quality effort and the application of good analytical and technical skills
- To observe GLP/cGMP at all times
- Testing of all laboratory samples including Raw Materials, Packaging Components, Product, Validation, Stability, Environmental, OH
- Performance of laboratory tests as per written procedure or as per pharmacopoeia
- Recording of analytical results accurately
- Operation, maintenance and calibration of laboratory instruments
- Preparation and execution of instrument and method validation protocols
- To maintain written training records
- To ensure that the laboratory is kept clean, tidy and safe at all times
- To report any non-conformance, instrument malfunction, accident or other abnormal occurrence to immediate superior
- Ordering, receiving and controlling laboratory chemicals, reagents and consumables.
- Receiving and controlling test samples.
- Ensure timely completion of all SOP, reading, training and assessment.
- BSc. (minimum) in science or a related discipline.
- Must have practical experience of HPLC, GC and KF analysis.
- Must have relevant experience in the pharmaceutical or related industry.
- Must have a minimum of 18 Months experience in an analytical lab.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.