A Data Integrity Specialist is required by CareerWise Recruitment for a 12-month contract position with our Waterford based pharmaceutical client. Tis is a hybrid position you would have to work 3 days on site and 2 days at home. If you have worked on CAPAs, managed the CSV system and led continuous improvements on Data Integrity then this is the position for you
THE ROLE
- 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
REQUIREMENTS
- Applicants must hold a qualification in a scientific or technical discipline.
- 2-5 years experience within a GMP setting.
📌 Data Integrity Specialist (Kingston)
🏢 CareerWise Recruitment
📍 Kingston
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