Data Integrity Specialist

Are you ready to lead cutting-edge data analysis that accelerate breakthroughs in biotech?

R&D Partners is seeking a dedicated Data Integrity Specialist 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.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• 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

Key Skills and Requirements:

• Strong understanding of data integrity principles and regulatory requirements.
• Ability to conduct thorough data quality checks and validations.
• Experience in creating and delivering training programs.
• Problem-solving skills to identify risks and implement effective solutions.
• Knowledge of proper documentation practices and computerized system validation.
• Strong communication and collaboration skills to work across departments.
• Ability to prepare for and participate in audits and inspections.

For more information, please contact Grant Van Schalkwyk

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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