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Details

CW Sr Associate QC (Senior) AMGNJP00029284


Reference:JSC00029284 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst, Nurse Associate


We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties


•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 Amgen 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.



Education & 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.



If you would like further Information you can contact the recruiter directly:


Jack Caffrey | Tel: +353 (0) 1 507 9279