Quality , Science, Pharmaceutical & Food

QC Systems Specialist

  • Contract
  • Remote
  • Dublin South
  • 41956301

PE Global are currently recruiting for a Senior Associate QC LIMS/ LMES/ CIMS/ Empower for a client site in South Dublin  –

12 month initial contract

 

Overview:

 

This job specification outlines the general responsibilities associated with the role of Senior Associate responsible for LIMS/ LMES/ CIMS/ Empower support.

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

  • Work with site business owners to provide laboratory business administration, implementation and technical support services for SM-LIMS, Accelrys Smartlab (LMES) and Accelrys CIMS (Inventory Management), Empower.
  • Build, develop and maintain LIMS templates.
  • Evaluate new or revised eProcedures in conjunction with lab SMEs.
  • Provide support for LMES eProcedure implementation e.g. CIMS updates and SOP updates.
  • Provide end user support for LIMS.
  • Review and Approval of Quality Documentation e.g. Sample Plans FORMs and Environmental Monitoring sample plans.
  • Contribute to Computer System Validation activities within the QC laboratory.
  • Develop and deliver training for laboratory LIMS/ LMES/ CIMS requirements in adherence to requirements, SOPs, Standards, GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systems.
  • Identify, manage and implement continuous improvement projects related to laboratory applications and improving user experience.
  • Work with site business owners to evaluate system practices for compliance and ensure the system’s application user operations procedures are accurate and effective for the application.
  • Partner with the global Master Data Group as needed.
  • Provide input on global level topics related to LIMS/ LMES/CIMS/ Empower.
  • Provide Instructor led training for QC laboratory applications.
  • Audit and Inspection preparation and participation.

 

 

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.
  • Familiar with 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.
  • Ability to identify and manage competing priorities.

 

Interested candidates should send their CV to mailtoAudrey.mccarthy@peglobal.net or call 0214297900

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