Job Reference: J5634128
Updated On: 05/01/2021
Status: Now Interviewing
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Role OverviewWe are currently looking for a Data Integrity Specialist to join a leading CDMO company based in the Kent area. As the Data Integrity Specialist you will be the point of reference for the Data Integrity compliance for the site. This will include understanding of ALCOA principles and the Data Integrity of all manufacturing and laboratory software driven equipment.
Key Duties and Responsibilities1. Assure compliance of all systems on site with Data Integrity Guidelines.
2. Administration of laboratory systems including the Empower 3 CDS system providing a Quality System to ensure the use of the system in compliance with regulatory guidelines.
3. Review of laboratory computer based systems and standalone systems to ensure compliance with principles of Data Integrity. Input to other departments systems if required. Implement remedial action plans were required.
4. Provide training to others on site in the requirements of data integrity.
Role Requirements1. Understanding of 21 CFR Part 11, GAMP 5 and MHRA GMP Data Integrity Definitions and Guidance for Industry Mar 2018.
2. Experience of Pharmaceutical Production and associated equipment and systems.
3. Familiarity and training on analytical software packages, database systems and laboratory informatics.
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