This position is responsible for carrying out tasks and duties related to analysis, material release, lab utilities and testing procedures as required by Good Manufacturing Practice (GMP).
* Achieves competency in laboratory methods and procedures.
* Performs analytical testing activities in relation to material release.
* 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 licence 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.
* Maintains and develops knowledge of analytical technology as well as cGMP standards.
* A minimum of 2 years experience in a laboratory-testing environment within the pharmaceutical industry would be an advantage.
* A third level qualification in a scientific/technical discipline required, ideally Microbiology based.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals.
* Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists