The Senior QC Analyst will be responsible for oversight of the chemistry laboratories, carrying out analytical testing of biologics products and ensuring global standards are met.
- The Senior QC Analyst will execute chemical and analytical methods to facilitate in-process testing and final release testing such as HPLC, UPLC and GC testing supporting the release of biologics product.
- Contribute effectively to the design and implementation of quality systems in QC Laboratory
- Participate, as directed, in equipment calibrations, equipment maintenance, laboratory auditing, LIMS data management
- The Senior QC Analyst will support execution of method validation/suitability
- Provide input support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
- Carrying out sampling and Analytical testing of Raw Materials, packaging materials and intermediated according to approved procedures
- Ensure that any deviations or out of specification results are reported immediately to the QC Executive so that corrective actions can be taken
- Provide assistance and guidance in deviation investigations, OOS investigations and batch disposition
- Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate).
- Actively support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
The next Senior QC Analyst should have a bachelors degree in chemistry or a related science with 4 years experience working in the pharma/biopharma industry. Experience in method validation and or transfer desirable but not essential.
If you're looking to join an innovative world leading biopharmaceutical company then send us your CV now!
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.