Data Integrity Specialist

CareerWise Recruitment; Waterford; Hybrid; EUR 52,000 - 70,000; Full time

Job summary

CareerWise Recruitment is seeking a Data Integrity Specialist for a 12-month contract with our Waterford pharmaceutical client. Hybrid role: 3 days on-site, 2 days remote.

You will ensure regulatory compliance, perform data quality checks, and drive CAPA and continuous improvement. Responsibilities include validating computerized systems, leading data integrity training, managing audits, and producing DI metrics for management.

Qualifications

• Qualification in scientific or technical discipline.
• 2–5 years experience within a GMP environment.
• Experience with data integrity, CAPA and validation of computerized systems.
• Ability to deliver training and manage regulatory inspections.

Responsibilities

• Ensuring regulatory compliance related to data integrity.
• Conducting data quality checks and validations.
• Developing and delivering training on data integrity principles.
• Managing risk assessments and remediation actions.
• Documenting storage, retrieval and data recording practices.
• Investigating data integrity incidents and implementing CAPA.
• Leading continuous improvement initiatives in data integrity.
• Overseeing validation of computerized systems for DI compliance.
• Supporting inspections and audits and generating DI reports.

Skills

GMP experience

Data integrity

Regulatory compliance

Training delivery

CAPA handling

Risk assessment

Analytical skills

Education

Scientific or technical degree

Job description

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 environment.

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