Job description
This role will provide support to our client's IT Product Information System Owner (IT Regulatory Affairs department) daily activities. This scope includes the following systems: - U-Pilot (Liquent Insight Manager / Product Information Tracker tool) - Pmpm (Packaged Medicinal Product Mapper): Internal developped delivered by DevOps team. Implementation not in the scope of this Job Description but future candidate should be able to follow-up on this implementation and work in close collaboration with DevOps team. - E2E Regulatory Information Transformation (Replacement of U-Pilot into Veeva Registrations Cloud application): project is on-going, currently in design phase - E2E Labeling & Artwork Visibility report projects: centralization of data coming out of 6 existing systems from QA, Regulatory, Supply Chain and SAP departments in an Oracle database where data consolidation (table mappings, creation of Views, applying some business rules) has to take place
What you'll do
- The candidate will be responsible for executing or facilitating daily IT System operations but also participating to the above projects. The main responsibilities will be: Facilitating, proposing, following-up and/or implementing system/technical Change Requests (sometimes implemented by other IT Teams)
- Writing SQLs in Oracle database and analyzing the outputted data
- Closely collaborating with EAI, DevOps, BI Analytics IT teams
- Authoring and maintaining IT System documentation (technical: Design Specification, Configuration Specification, Functional Specification,... / Tests: OQ tests scripts and ensure their execution)
- Managing review & approval workflows of those documents
- - Performing or coordinating support activities of those Systems like: o IQ/OQ's execution o Periodic Reviews o DRP Plan o Servers/Database restart mainly through liaison with our internal support teams o ...
Required Skills
- IT background (University or Bachelor degree in computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GxP role as IT System Manager & IT validation) to be able to understand how a system works
- Technical Expertise in Oracle databases and more precisely ability to write complex Oracle SQL queries/views
- Familiar with EAI, WebServices, Cloud Applications, Qlik Sense & Cognos, DevOps technologies
- Strong working knowledge of the validation lifecycle for computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures
- Working knowledge of general GxP & Change Control processes
- Fluent in English, French is a plus
- Strong interpersonal, oral and written communication skills as there is a high degree of collaboration required mainly between members of Global Regulatory Affairs, Supply Chain, QA (Business and IT), IT Compliance as well as other IT or Business functions
- A detail-oriented approach to deliverables
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