About the role
Overview Our Team / Overview The aim of the role is to ensure that Data Integrity is embedded in all aspects of work performed at the site and ensure that regulatory and global quality requirements are cascaded to site functions so that all Data Integrity requirements are met.
Responsibilities Main Accountabilities Ensure compliance with regulatory requirements and company policies related to data integrity.
Conduct routine data quality checks and validations to identify and address data integrity issues.
Develop and deliver training programmes on data integrity principles and best practices.
Identify and assess risks related to data integrity and implement appropriate mitigation strategies.
Ensure proper documentation practices are followed, including data recording, storage and retrieval.
Investigate data integrity incidents, including potential data breaches or data falsification, and implement corrective and preventive actions (CAPA).
Lead continuous improvement initiatives to strengthen data integrity practices.
Oversee the validation of computerised systems to ensure they meet data integrity requirements.
Ensure inspection readiness and participate in regulatory inspections and audits related to data integrity.
Generate and review data integrity reports and metrics for management, including the Data Integrity Maturity Model (DIMM).
Represent the site within global data integrity forums and communicate relevant updates locally where required.
Key Roles (D, A, I) Establish and prioritise data integrity objectives for the site (D).
Proactively identify remediation actions from findings arising from internal and external audits (A).
Qualifications Bachelor’s degree in Science, Engineering, Pharmacy, Quality or a related discipline.
5+ years’ experience working within a GMP-regulated pharmaceutical, biotechnology or medical device manufacturing environment. Strong understanding of Data Integrity principles, including ALCOA+ and applicable GxP regulations.
Experience supporting regulatory inspections and internal/external audits.
Knowledge of computerized system validation (CSV) and electronic quality systems.
Experience conducting investigations, risk assessments and implementing CAPA.
Excellent written and verbal communication skills with the ability to influence cross-functional teams.
Experience developing and delivering training on quality or data integrity topics.
Strong analytical, problem-solving and continuous improvement mindset.
Ability to manage multiple priorities while working independently and collaboratively.
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