SENIOR ASSOCIATE QC (LIMS / LMES / CIMS / EMPOWER) TECHNICAL SUPPORT required by CareerWise for our BioTech client in South County Dublin.
The SENIOR ASSOCIATE QC (LIMS / LMES / CIMS / EMPOWER) TECHNICAL SUPPORT will work with site business owners to provide laboratory business administration, implementation and technical support services for SM-LIMS, Accelrys Smartlab (LMES) & Accelrys CIMS (Inventory Management) and Empower.
Role of this position
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.
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.