Data Integrity Officer

Employer
Marketplace Technical
Location
Northumberland, UK
Salary
Competitive
Closing date
1 Nov 2020

View more

Sector
Technology & New Media
Contract Type
Permanent
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Truly global Pharmaceutical Company seeks an experienced Data Integrity Officer.

Duties may include:

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.
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.
Ensure all procedures used within the laboratory environment which have been identified as relevant to data integrity are correct, current, and available.
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.
Knowledge in laboratory systems including Empower 3 to ensure full regulatory compliance.
Work with the Quality function and the IT department to implement company policies with regards to data integrity.
Provide Data integrity support to the Site, liaising with other sites within the organisation where appropriate.
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 IA generation for new site equipment purchases from a data integrity perspective.
provide timely support to departments on site as required.
Work closely with Quality and Technical departments to understand software and data integrity compliance issues.
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.
Take responsibility for your own technical skills-development and seek additional training where necessary.
Provide training to other staff in the regulatory data integrity guidelines and company policies as appropriate.
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.
Familiarity and training on analytical software packages, database systems and laboratory informatics.
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 analytical testing in a pharmaceutical environment or experience in the production systems.
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.
Project management skills
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