QC In Process Analyst
This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures as required by Good
Manufacturing Practice (GMP).
* Achieves competency in laboratory methods and procedures.
* Trains other QC analysts in laboratory methods and procedures when required.
* Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
* Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
* Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
* Performs routine and non-routine analytical testing activities.
* Review and approval (where appropriate) of laboratory test results.
* Ensures that testing and results approval are completed within agreed turnaround times.
* Deals with non-conformances/ deviations in an accurate and timely manner.
* Deputizes for the QC Team Leader as appropriate.
* In process control testing and activities to support the production units.
Qualifications and experience
* A third level qualification of a scientific/technical discipline is required.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
If this role interests you, please contact me on email@example.com for more information
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.