Join our team working on projects of one of the largest pharmaceutical companies in the world and have a real impact on the lives and health of more than 15 million patients! By implementing the projects of Sii's key, long-standing client, you will get the chance to develop in the field of R&D, clinical trials and global services. You will work based on Agile methodologies, using modern tools and technologies.
We will ensure the continuity of your employment, at the same time giving you the opportunity to change your project or project team at any time. You will be also offered regular in-house training and specialist workshops. Remote work, work at the office or flexible working hours – the choice is 100% yours.
- Determine validation approach, identify deliverables needed or impacted by a project / enhancement / or change for GXP computerised systems
- Responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance
- Provide estimates and forecast validation activities for a project
- Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life
- Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions
- 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
- Experience in leading validation for projects and systems maintenance, as well as in authoring validation plans, reports and deliverable registries
- Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated)
- Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
- Fluent (written and spoken) English – we work in international teams and set ups
- Pakiet medyczny
- Pakiet medyczny dla rodziny
- Pakiet sportowy
- Pakiet sportowy dla rodziny