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Sr Associate Quality Control LIMS/LMES/ CIMS/ EMpower - Ireland  

Company managed [?] Still accepting applications
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Posted on : 01 May 2017

Project Description

  • This job specification outlines the general responsibilities associated with the role of Senior Associate responsible for LIMS/ LMES/ CIMS/ Empower support at our company.
  • This role will be responsible for administration and technical support in conjunction with the BPO for the QC Enterprise systems LIMS/ LMES/ CIMS/ Empower.
  • Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities
  • Provide Laboratory IS administration and implementation and technical support services for SM- LIMS, Accelrys Smartlab (LMES) and Accelrys CIMS (Inventory Management), EMpower
  • Build, develop and maintain LIMS templates, LMES eProcedures, CIMS templates
  • Evaluate new or revised e Procedures in conjunction with lab SMEs
  • Provide support for e Procedure implementation e.g. LMES method info, method trending info, SOP updates
  • Troubleshoot laboratory methods in LIMS and resolve issues
  • Review and Approval of Quality Documentation e.g. Sample Plans, Forms, SOPS
  • Contribute to Computer System Validation activities within the QC laboratory
  • Facilitate IT projects within the company  such as network upgrades, disaster recovery and migration activities
  • Develop training documentation and SOP’s for laboratory LIMS/ LMES/ CIMS requirements in adherence to company requirements, SOP’s, Standards, GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systems
  • Manage and implement projects to maintain, develop and support Lean Laboratory practices such as review by exception, paperless lab systems etc
  • Ensures the system’s application user operations procedures are accurate, effective and being followed for the application, user responsibilities, user roles, access privileges and training requirements per role
  • Partner with the global Master Data Group as needed
  • Manage and support any additional QC IS projects as required
  • Represents QC on global level topics related to LIMS/ LMES/CIMS/ EMpower and QC IS Solutions
  • Provide Instructor led training for QC IS systems
  • Support for Password administration and session unlocking
  • Audit and Inspection preparation and participation
  • Evaluate system practices for compliance and operational excellence improvement on a continuous basis

Knowledge and Experience:
  • Hold a third level qualification in a Science related discipline
  • Minimum 4 years experience in a Biotechnology/ Pharmaceutical/ GMP Environment with previous experience as a user (as a minimum) for LIMS/LMES/CIMS/ Empower or administration experience
  • Familiar with (or can learn) new laboratory information systems and can self-teach technical topics
  • Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP
  • Knowledge on Data Integrity Assessments (DIA) for computerised systems and execution of CFR 21 Part 11 for computerised systems.
  • Excellent Organisational Skills and Time Management
  • Strong Communication Skills
  • Ability to work under minimal supervision