Quality Compliance Systems Specialist

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Quality Compliance Systems Specialist (Kent)I am currently working with an exciting CDMO Pharmaceutical company in Kent who are looking for a Quality Compliance Systems Specialist to join the team on a permanent basis. Function:Management, coordination and support of activities relating to the maintenance , development, troubleshooting, auditing and validation of GMP-relevant IT application systems and IT infrastructure components, such as Trackwise, Empower, Tiamo 2.5, WinLab UV, TruScan 2.6.0, TOC DataPro900 0.1.51, Spectrum 2, Lab Network, LabX, SEAL CSFAs, Agilent Baths.Ensure GMP environment systems and software validation and process compliance with internal policies and external (Data Integrity, FDA, ICH and MHRA) regulations. Ensure QC Systems and data comply with Data Integrity regulations.Responsibilities:Create, maintain and modify user accounts and passwords on GMP relevant application systems and IT infrastructure components.Create and maintain methods in Laboratory Computer systems.Validate new software and systems.Perform troubleshooting and monitor server space to prevent downtime and unexpected failures.Launch, lead or support project activities linked to the implementation of new or changes to existing Quality IT systems and softwares.Run monthly QC project meetings with IT, Validation, QCCCTS and QC to update status of ongoing projects.Complete Data Integrity assessments of all QC systems and data generated by Quality Control.Requirements:Excellent knowledge in the field of quality assurance of Computerised Systems including FDA (CFR Part-11) compliance requirements.Excellent knowledge of Qualification of IT infrastructure and Validation of Computerised Systems within a GMP regulated environment.Thorough knowledge of GMP requirements.Knowledge of SAP regarding set-up of items and certification of test resultsIf this Quality Compliance Systems Specialist looks like it could be the next step in your Pharmaceuticals career, please get in touch ASAP! To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales