* Manage new Laboratory Instrumentation/Equipment procurement projects up to Performance qualification stage to meet required timelines. Acts as business owner for instrumentation lifecycle, commissioning and qualification documents.
* Leadership activities including selection, development, coaching and day to day management. Ensure that the team receives appropriate resources and programs to develop technical and other skills.
* Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues for all laboratory equipment and systems including Empower and LIMS.
* Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and procedures for various systems; ensure all work is subsequently carried out in line with same.
* Facilitate the laboratory systems and instrumentation daily team meeting and ensure team representation at required cross functional forums.
* Ensures all routine and non-routine Laboratory system equipment maintenance is completed as required. Ensures instrumentation projects, PM's and Calibrations are performed to meet the laboratory testing schedules.
* Manage laboratory systems and instrumentation budget and costs including management of outsourced instrument calibration and maintenance activities and ensure financial compliance within the team. Develop financial awareness for all team members.
* Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc, all under aseptic/clean room conditions. Provide input, review and approval for atypical, observation, and process capability investigations. Oversee coordination of resources to implement suggestions/ideas of merit. On assignment, and depending on experience, participate in or lead departmental initiatives on improved compliance and quality systems.
* Participate in the generation and update of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
* Manage and contribute to the achievements of department productivity and quality goals
* Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
* Third level qualification (Degree) in a science related discipline, ideally in Chemistry or Analytical Chemistry.
* 5 years of experience in a supervisory or managerial role in a pharmaceutical Laboratory
* Considerable experience and technical troubleshooting skills, particularly with analytical equipment performance.
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The Life Science Specialists