LIMS Analyst

LIMS Analyst

Jenn Dinan at Wallace Myers is recruiting a LIMS Analyst to work in the Data Integrity Stream on contract at our Global Biopharma client's site in Waterford.

The focus of this role is to retrospectively update existing LIMS analyses (for Micro and chemistry labs) to optimize LIMS automation features like automated calculations and report/dashboard development. A key element of the role is to automate interfaces between QC equipment and LIMS. Experience with Sample Manager LIMS, and experience of working with LIMS suppliers and stakeholders is critical.

An experienced LIMS professional with strong DI understanding and hands on experience of configuring LIMS analyses and QC equipment integration (Thermo Sample Manager LIMS).

Job Purpose

The aim of the role is to ensure that Data Integrity is embedded in all aspects of work performed in Waterford and ensure that Regulatory and Global Quality requirements are cascaded to site functions to ensure that all Data Integrity requirements are met

Main Accountabilities

• Ensuring compliance with regulatory requirements and company policies related to data integrity
• Conducting regular routine data quality checks and validations to identify and address any data integrity issue
• Developing and delivering training programs on data integrity principles and practices
• Identifying and assessing risks related to data integrity and implementing mitigation strategies
• Ensuring proper documentation practices are followed, including data recording, storage, and retrieval
• Investigating data integrity incidents, including potential data breaches or falsification incidents, and implementing corrective and preventive actions (CAPA)
• Leading continuous improvement initiatives to enhance data integrity practices
• Overseeing the validation of computerized systems to ensure they meet data integrity requirements
• Ensuring inspection readiness and participating in regulatory inspections and audits related to data integrity
• Generating and reviewing data integrity reports and metrics for management, especially the DIMM (DI Maturity Model)
• Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication
• Establish and prioritize data integrity objectives for the site
• Proactively identify remediation actions from findings from internal and external audits
• Identify training needs and content for data integrity
• Decide on corrective and preventive actions for data integrity issues
• Is informed of any breach in data integrity
• Advise on cross-departmental data integrity strategies
• Is informed of inspections and audits outcome

All applications will be treated with the strictest of confidence

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