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