* Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of biotechnology products.
* Coordinates equipment qualification activities for laboratory equipment.
* Ensures qualification documentation and activities are completed, reviewed and approved within agreed turnaround times.
* Initiates and leads risk assessment, gap analysis and deviation management for commissioning of, changes to or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Control laboratories.
* Completes periodic reviews of laboratory instruments and associated instrument control software with focus on change control, deviation investigations and CAPA to ensure compliance and validated state of the instrument.
* Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
* Trains other QC analysts and Manufacturing personnel in laboratory methods and procedures when required.
* Writes/updates and reviews TMs, SOPs and WIs as required.
* Initiates and drives change controls to completion to implement process improvements.
* Actively participates in JBIL lean initiatives such as Kaizen, 5S and Gemba.
* Is an active member of the QC group and provide assistance with other group activities as required.
* Communicates relevant issues to the QC Team Leader promptly.
* Equipment qualification, i.e URS, IQ/OQ etc.
* Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines
* Deputizes for the QC Team Leader as appropriate.
* Maintains and develops knowledge of analytical technology as well as cGMP standards.
* Partners with other departments to ensure that all QC testing activities are completed in a compliant and efficient manner
* BSc (Hons) in a scientific/technical discipline.
* A minimum of 2 years' experience in a QC laboratory environment within the biological and/or pharmaceutical industry.
* Understanding and knowledge of qualification requirements for laboratory equipment.
* Ability to operate as part of a team is critical.
* Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory
* Good knowledge of LIMS, Trackwise and Electronic documentations systems.
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