SKILLS BRIEF

• Significant experience in a software and IT systems focused compliance and/or validation role in a Pharma, Life Sciences or Biotech manufacturing environment.
• Experience developing the testing strategy and architecture for medium to large projects in the same manufacturing environments.
• Strong experience in the development and modification of test scripts.
• Significant systems documentation experience in the support of validation activities.
• A strong understanding of and hands on experience with CSA (Computer Software Assurance Validation).
• Experience in the validation of AI focused solutions and of AI usage in the regulated validation sector.
• Proven Project Management and leadership experience and ideally a recognized Project Management qualification.

THE ROLE

• IT Compliance Lead
• Remote role (Ireland)
• This role is remote with regular travel. The candidate must be based in Ireland with a valid work permit
• Contractor or permanent opportunity

ROLE BRIEF

Operating in this role for a major NNIT Ireland client you will oversee IT Compliance testing of new or modified applications/systems across multiple computing
environments. You will be responsible for applying IT and Compliance knowledge and experience to analyze requirements against test cases, reviewing and approving test cases.
You will leads the IT Compliance activities within a project or multiple projects within a single client area. You will also prepare and approve documentation per policy and procedure to support the certification of an application/system while providing primary support to project and IT staff related to SLC, validation and compliance process and procedures.

Core Responsibilities:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Develop the testing strategy and architecture for medium to large projects.
• Participate in the development and or modification of automated test scripts.
• Develop, review and approve system documentation (test plans/strategies, other SLC documentation) in support of validation activities.
• Lead the development and execution of test plans.
• Communicate project progress by producing project reports to provide timely and accurate status to Project team.
• Resolve issues that may delay the project or otherwise subject the NNIT Ireland client to financial or regulatory risk.
• Establish project tasks and timelines and deliver upon those.
• Capture and report on IT Compliance data and metrics for assigned project tasks and identify potential process improvements.
• Ensures IT Compliance tasks stay within project budget and/or estimates and assist in the establishment of regulated policies and procedures at the departmental level.
• Establishes and maintains productive relationships with all levels in the Divisional IT organization, and business function.Acts as a liaison and IT Compliance expert to assure successful implementations.
• Monitor and coordinate the IT Compliance efforts within a project.
• Guide the efforts of junior staff.
• Independently design and develop general approaches to the solution of systems problems which require application of basic IT compliance principles.