Our South Dublin multinational pharmaceutical client has a fabulous opportunity for a QC LIMS/Instrumentation Analyst.
- To support the maintenance of the validated status of the LIMS system to assure compliance with applicable regulations as well as company policies and procedures.
- To develop and maintain required documents, including SOPs, specifications, and forms for the LIMS system, in conjunction with QC\QA Department Managers and\or Designee(s).
- Execution, review and generation of validation and data migration protocols and reports in compliance with Regulatory, GMP and GLP guidelines.
- Recording of any validation deviations using the LIMS Incident Management and Change Control module
- To facilitate dialogue\support between the LIMS Vendors and the system users, to troubleshoot and resolve issues.
- To identify and support the implementation of functional area end-user requirements and enhancements.
- To deliver LIMS system training as appropriate to LIMS Users and\or the functional area, and to maintain adequate records.
- To identify report requirements for functional areas, to design\develop or assist in design\development of reports.
- To provide support to other business systems with respect to the interface with LIMS, to assist in developing instrument integration and data acquisition.
- To assist in validation activities (IQ, OQ, PQ) as required, coordinating and\or executing various portions of system validation, for example performance qualification.
- To ensure the system static data is updated in a timely manner as required by the functional area Manager\designee.
- To work in conjunction with the LIMS Users to ensure compliance across all user groups.
- To liaise with QC, QA and IT Departments in the performance of normal duties.
- To maintain the validated status of all Instrumentation as situated in the QC Laboratories.
- To implement, where applicable, a programme of Preventative Maintenance and Vendor Support for QC Instrumentation.
- To provide Instrumental troubleshooting support.
- To update and maintain all relevant documentation concerning Instrumentation i.e. IQ, OQ, PQ, SOP.
- To source and purchase new Instrumentation, where directed, ensuring that said Instrumentation is qualified according to applicable standards.
- To ensure that all relevant Instrumentation is calibrated according to our client’s procedures, in an accurate and timely manner.
- To ensure the maintenance of all Clients within the QC Laboratories.
BSc. (minimum) in science or a related discipline.
- Minimum of 3 years’ experience in a Quality Control laboratory environment.
- Minimum of 1-2 years’ experience as a LIMS system administrator
- Have relevant instrumentation experience in a pharmaceutical environment
- Have good organisational, communication, interpersonal and report writing skills.
- Excellent organisation skills.
- Good decision making skills.
- Will be proactive and flexible
- Full understanding of cGMP requirements, ICH guidelines, Ph. Eur requirements along with EMEA guidance, Annex 11 and Compliant GxP Computerized Systems (GAMP5).
- Ability to work independently and as part of a team.
- Strong attention to detail.
· The proven application of good analytical and technical skills.
Contact Kate at Jacksonstone Recruitment on 01 274 4444 for further information regarding this and similar roles quoting Jacksonstone's website as your reference. Established in 1999 we recruit primarily throughout Wicklow, Dublin and Wexford. Jacksonstone Recruitment span a diverse range of clients from SMEs to large multinational corporations in many sectors including Office Staff, Accountancy & Finance, Financial Services, Sales & Marketing, Customer Service, Retail, Production & Manufacturing, Biotechnology, Pharmaceutical Life Science, Supply Chain, Logistics, Engineering, Quality Control, QC Analysts, Biochemist, Temp jobs, Contract vacancies and Permanent roles. Visit our website www.jacksonstone.ie for details of other opportunities.