Main Purpose and Objectives of Position: Responsible for ensuring that materials and products are analyzed in accordance with current Good Manufacturing Practices, conform with regulatory commitments and meet all required quality standards both during and on completion of analysis.
Ensures that site and corporate quality polices related to the analysis of GMP materials are followed.
Responsible for operational and technical support of the electronic systems used to perform analytical testing, recording and reporting analytical test results. The electronic systems include systems such as Water's Empower chromatography data system, NuGenesis eLN, Biovia's Smartlab LES system and Thermo Scientifics' Darwin LIMS system.
Educational Requirements: May hold BSc, MSc, or PhD in Chemistry, Biology, Microbiology, Engineering or related discipline.An IT primary degree would also be acceptable combined with at least 5 years Laboratory Experience in a Pharma Environment. Experience or a Strong Aptitude in the area of LaboratoryE-Systems is also required.
Key Responsibilities: Acts as system administrator for E-Systems utilized in the laboratory (e.g. Empower, Smartlab, LIMS).
Acts as primary contact with IT in regards to system upgrades and validation ofelectronic systems used across the laboratory.
Acts as primary contact to global system representatives. Influence future global solutions before deployment to the Kinsale site.
Assure that all E-Systems used in the testing of raw materials, in-process samples, intermediates or final products are appropriately validated and remain in an ongoing validated state.In the event of non-conformance to acceptable quality and/or safety standards, ensure appropriate investigations are undertaken and documented, using Root Cause Analysis techniques where appropriate.Ensure all associated countermeasures are complete.
Champion the QCL initiatives towards paperless laboratories e.g. elimination of paper, automatic capture of data, elimination of transcription, scripting program etc.
Review and approve analytical procedures, investigations, and deviations.
Own and review change controls pertaining to E-Systems.
Provide guidance and training to other team members on updates to the cGMPs, which pertain to QCL E-Systems testing.
Keep current with cGMPs.
Support the writing of periodic reports and system validation documentation.
Provide technical support to Lab analysts and other technical staff.
Liaise with equipment team for installation and qualification of analytical equipment in accordance with local procedure and determine any E-Systems requirements.
Assist in developing, implementing and maintaining the Lab Quality System.
Assist in ensuring that analytical operations are undertaken safely.
Assist in developing Site Quality Systems.
Support and participate in self inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, Food and Drug Administration, etc.
Ensure that appropriate analytical technology is used for new and existing processes and equipment to the site.Where required develop and validate the appropriate technology and facilitate transfer of analytical methods to & from other manufacturing sites & development organization, where required.
Work with production teams to improve the state of validation and drive variability reduction.
Assist in education of teams in the role and capability of the Quality Control Laboratory Team.
Benchmark best practices for analytical technology and operations and implement appropriate improvements.
Provide input to operation of associated team.Participate where required in the development and implementation of business plans.
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