Data Integrity Specialist, Kent

Global Pharmaceutical Manufacturer seeks a Data Integrity Specialist with an understanding of ALCOA principles and experienced in the Data Integrity of manufacturing and laboratory software driven equipment. Duties will include but are not limited to: Assure compliance of all systems on site with Data Integrity Guidelines Administration of laboratory systems Review of laboratory computer-based systems and standalone systems to ensure compliance with principles of Data Integrity. Review and gap analysis of Production Equipment and systems - both computer based and paper based- for data integrity compliance Provide support during audits and regulatory inspections with regards to Data Integrity. Provide training to others on site in the requirements of data integrity. Provide support to QA to enable audits of laboratory and production computerised systems to be effective. Raise Change Control/deviations as required. Ensure that relevant regulatory updates to data integrity are captured and integrated into the sites policies and procedures. Ensure that the updates for key software systems are correctly assessed for suitability and implemented following the correct procedures when necessary. Work with the Quality function and the IT department to implement company policies with regards to data integrity. Co-ordinate/support installation of new laboratory equipment including all related documentation and training from a computerised system and data integrity perspective. Provide support to URS generation for new site equipment purchases from a data integrity perspective. Ensure own time managed appropriately. Ensure plans exist for projects associated with role. Provide representation to project meetings from a data integrity perspective and ensure work is performed to plan. Ensure equipment audits are performed to schedule for instruments and processes covered by this role. Assist in coordinating any corrective action identified. Manage all Trackwise actions required to assure compliance with Data Integrity Take responsibility for your own technical skills development, and seek additional training where necessary. Liaise with external Data Integrity forums to develop knowledge Skills and experience: Understanding of 21 CFR Part 11, GAMP 5 and MHRA GMP Data Integrity Definitions and Guidance for Industry Mar 2018 Familiarity and training on analytical software packages, database systems and laboratory informatics. Familiarity of Production and Office Equipment and related software. Knowledge of ALCOA and Good Documentation Practice Knowledge of Spreadsheet validation Broad knowledge of GMP, validation and regulatory issues. Good written and verbal communication skills. IT problem solving skills. Project management skills. Experience of Pharmaceutical Production and associated equipment and systems Experience of analytical testing in a pharmaceutical environment The ability to keep up to date with industry regulatory changes, to communicate these to the group and to plan/prioritise any necessary implementations to current standards. Gap analysis skills Project management skills