About the Company
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 (CDS), Biovia's Smartlab system, NuGenesis Electronic Laboratory Notebook (ELN), Thermo Scientific Darwin Laboratory Information Management System (LIMS) and Lonza's MODA.
About the Role
Responsible for ensuring that materials and products are analysed 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 policies related to the analysis of GMP materials are followed.
Responsibilities
* Acts as system administrator for E-Systems utilized in the laboratory (e.g. Empower, Smartlab, LIMS, NuGenesis).
* Acts as primary contact with IT regarding system upgrades and validation of electronic systems used across the laboratory.
* Acts as primary contact to global system representatives.
* Assure that all raw materials, in-process samples, intermediates or final products are appropriately analysed and authorised.
* 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.
* 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 testing.
* Keep current with cGMPs.
* Investigate and report on customer complaints and recommend countermeasures.
* Support the writing of E-Systems Computer Systems Validation (CSV) documents.
* Provide technical support to Lab analysts and other technical staff.
* Support the qualification of E-Systems connected analytical equipment in accordance with local procedure.
* Assist in ensuring that lab equipment is satisfactorily qualified and maintained.
* 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.
* Assist in education of teams in the role and capability of the Quality Control Laboratory Team.
* Provide input to operation of associated team.
* Participate where required in the development and implementation of business plans.
* Support the timely closure of Non-Terminal Data in QCL E-Systems.
Qualifications
May hold BSc, MSc, or PhD in Chemistry, Biology, Microbiology, Engineering or related discipline.