Ordina’s Quality & Compliance team is highly educated, multidisciplinary, intensively trained, rich in practical experience and recognized by our customers as a valued partner in quality services. Our team members have a depth of knowledge of regulations, standards, guidelines and industry best practices (GxP, 21 CFR part 11, ICH, QMS, ISO,…).
The Ordina Q team consists out of Validation Engineers/Trainees, Validation Coordinators and Validation Managers offering advice, training, and support for all GxP activities and projects in areas ranging from process & product support to software & process validation, quality control and quality management systems. Following a science and risk-based approach, Ordina identifies the critical steps in processes, and helps to improve the effectiveness and efficiency of validation and documentation efforts.
As a Computer System Validation Engineer, you will support our customers in setting up and maintaining IT systems and solutions falling under regulatory requirements (GxP, 21 CFR Part 11,…). As a part of a project team on the customer side, with support of technical solution experts and developers, you prepare, execute, and finalize the validation of computer systems to be used in the production or development of pharmaceutical products. You are a competent partner for our customers in questions concerning computer system validation.
You are responsible for the execution of validation activities such as validation planning, preparing user specifications and verification documentation, SOP’s, …
You are able to complete training materials and provide training on topics that are in your area of expertise.