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). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.
* Achieves competency in laboratory methods and procedures.
* 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.
* Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
* Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
* Deals with non-conformances/ deviations in an accurate and timely manner.
* Maintains and develops knowledge of analytical technology as well as cGMP standards.
* In process control testing and activities to support the production units.
* A third level qualification of a scientific/technical discipline is required.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Contact Emer on 0860437889 for more information or a confidential discussion on the role!