Senior Advisory Consultant

Role Purpose

Ideagen is the invisible force behind many things we rely on every day - from keeping airplanes soaring in the sky, to ensuring the food on our tables is safe, to helping doctors and nurses care for the sick.

So, when you think of Ideagen, think of it as the silent teammate that's always working behind the scenes to help those people who make our lives safer and better.

Every day millions of people are kept safe using Ideagen software. We have offices all over the world including America, Australia, Malaysia and India with people doing lots of different and exciting jobs.

The Senior Advisory Consultant will lead CSV projects on behalf of customers in alignment with GxP expectations and customer requirements. Their daily activities include authoring project-related CSV documentation, including Validation Plans, System Requirement Specifications, Design/Configuration Specifications, Risk Assessments, IQ/OQ/PQ Protocols and Reports, Traceability Matrices, Data Integrity Assessments, and Validation Summary Reports.

THIS ROLE IS UK HOMEBASED.

Responsibilities

- Manage and coordinate formal testing of computerised systems, including planning and writing of test cases, coordination of resources, execution of testing, completion, and approval of documentation.
- Follow Good Documentation Practises and adhere to Data Integrity requirements for completion of all documentation.
- Complete any allocated training (internal and customer requested) on time and in full.
- Investigate and troubleshoot any potential software issues/bugs.
- Communicate any software bugs or required updates as appropriate to software developers/vendors for appropriate resolution.
- Review computerised systems used in GxP processes to determine impact and develop a risk-based approach to meet global regulatory and customer requirements.
- Review CSV documentation to ensure data integrity expectations are maintained.
- Ensure project timelines are met to support customer commitments.
- Escalate any issues in a timely manner to ensure appropriate resolution.
- Perform and report 3rd Party audits on behalf of customers.
- Proactively highlight any areas for process improvement and actively contribute and participate in any internal continuous improvement initiative.
- Team Player – contribute knowledge to the IT Governance team, support more junior colleagues in their projects, help develop processes and good practises in project delivery.

Skills and Experience

- At least 3-5 years of experience with computer system validation.
- Degree in a science/health-related or IT-related subject or equivalent experience.
- Fluency in written and spoken English.
- A knowledge and understanding of a wide range of different types of systems used within the life sciences including MES, QMS, ERP, LIMs, SAS, SAP, etc.
- A knowledge and understanding of the requirements related to 21 CFR Part 11, EU Annexe 11, Data Integrity, and GAMP.
- Experience in handling regulatory inspections and audits is an advantage.
- Computer literacy, including proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint,
- Ability to self-motivate

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