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Data Integrity Specialist

Marketplace Group
Job LocationKent
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

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
    • Required skills
  • Data Integrity
  • GMP
  • GAMP 5
  • ALCOA

    • Keyskills :
    Data Integrity GMP GAMP 5 ALCOA

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