Data Integrity Specialist
About this role
SUMMARY
As our Data Integrity Specialist, you will serve as data integrity subject matter expert for a pharmaceutical manufacturing environment.
The Data Integrity Specialist will be a key member of the operations team, working closely with Quality Assurance, and will ensure the integrity of electronic data for manufacturing and QC equipment supporting batch disposition activities.
This role plays a critical gatekeeping function in batch disposition and is responsible for identifying discrepancies in electronic data and ensuring timely corrections and robust documentation.
The Data Integrity Specialist is responsible for ensuring compliance with cGMP requirements, applicable regulations, and company policies related to data integrity.
In this role, you will report to the Head of Operations.
Responsibilities
- Review electronic data, including system audit trails, for manufacturing and QC equipment to support batch disposition, ensuring that data integrity principles (ALCOA+) are applied consistently across all reviewed documentation.
- Identify and escalate critical and major data integrity deviations to Operations and Quality Assurance leadership and collaborate with laboratory and operations management to resolve data discrepancies.
- Author and review deviations and change requests related to data integrity.
- Create and developoperational data integrity practices in cooperation with stakeholders.
- Write, revise, review, and approve site procedures and policies related to data integrity.
- Contribute to the development of validation policies for computerized systems and ensure appropriate system maintenance in collaboration with the CS QA team and internal stakeholders.
- Participate in regulatory authority inspections (e.g. Fimea, FDA).
- Perform periodic system audit trail reviews across the site.
- Collaborate on internal audits of GMP quality systems and subsystems, with a focus on data integrity.
- Review and compile the Annual Product Quality Review (APQR).
- REQU