QC Process Analyst
Berkley Group
- Cork
- Contract
- Full-time
- 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.
- 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.
- Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.
- Deals with non-conformances/ deviations in an accurate and timely manner.
- Deputizes for the QC Team Leader as appropriate.
- Maintains and develops knowledge of analytical technology as well as cGMP standards.
- In process control testing and activities to support the production Units
- Liaisons with Operations department regularly throughout the day to ensure testing activities are completed in an efficient manner and issues rectified
- A third level qualification of a scientific/technical discipline is required.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
professionals for organisations throughout Ireland; for more information go to www.berkley-group.comIf you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Fred Chesne on +353 85 178 6539 or send your CV to fchesne@berkley-group.com.