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Data Integrity Officer

Marketplace Group
Job LocationKent
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Truly global Pharmaceutical Company seeks an experienced Data Integrity Officer to 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.Duties may include:

  • Assure compliance of all systems on site with Data Integrity Guidlelines
  • 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.
  • 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.
  • Review and gap analysis of Production Equipment and systems - both computer based and paper based- for data integrity compliance
  • Provide support during customer audits and regulatory inspections with regards to Data Integrity.
  • Provide training to others on site in the requirements of data integrity.
  • Develop knowledge of Empower CDS system to provide continuous improvement environment in terms of efficiency and use of the system.
  • 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 such as Empower are correctly assessed for suitability and implemented following the correct procedures when necessary.
  • Identify and produce or organise all documentation for laboratory computer systems validation where appropriate.
  • Liaise with suppliers to ensure instruments and associated software meets the requirements of 21 CFR Part 11 and MHRA GxP data integrity guidance.
  • 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.
  • 2 (3) 22. Manage all Trackwise actions required to assure compliance with Data Integrity
  • 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
  • Knowledge of Empower software.
  • 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.
  • Advanced Knowledge of Empower software.
  • Gap analysis skills
  • Project management skills.
    • Required skills
  • Data Integrity
  • GMP
  • GAMP 5
  • ALCOA

    • Keyskills :
    Data Integrity GMP GAMP 5 ALCOA

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