Description
Global pharmaceutical company are seeking a QC Specialist to join there QC team within there brand new plant.Day to Day:
- Approval and Release of Analytical data
- Generation, completion, review and approval of protocols - Method Validation/Development/Verification/Transfer and Instrument Validation
- Management of Technical Transfer, Compendia Verification and Method Validation
- Performing, scheduling and approval of calibrations and preventative maintenance of laboratory equipment.
- Ensuring timely completion of Laboratory Investigation and deviations
- Acting as a lead investigator for laboratory investigations
- Ensuring all related procedures and documentation are completed and maintained in line with GMP and Site procedures
- Competing non-routine / complex assignments and responsibilities with minimal supervision.
- Ensuring strict adherence to site policies/procedures, GMP and environmental, health and safety regulations
Requirements:
- Minimum of a Bachelor of Science Degree
- Minimum of 5 years relevant experience in a Pharmaceutical Laboratory
- Extensive experience in a laboratory Quality Control environment
- Experience in method transfer/verification/validation
- Experience of Dry Power Inhaler testing would be an advantage
- Must be a clear communicator and able to make clear reasoned decisions under pressure
- Experience of front line regulatory interaction (e.g. IMB, FDA)
- Must have effective problem solving skills
To hear more about this excellent opportunity please contact me Anna Mooney on or reply with an up to date CV.