IT System Manager
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: IQ/OQ’s execution, periodic reviews, DRP plan, Servers/Database restart mainly through liaison with our internal support teams, ...
- 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
What we offer
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo
- Nijverheidslaan 3, - Strombeek-Bever