Senior Validation Specialist
- WarszawaWarszawa, mazowieckie
- ogłoszenie wygasło rok temu
- Umowa o pracę, Umowa o dzieło
- Pełny etat
- Starszy specjalista (Senior)
- praca zdalna
- rekrutacja zdalna
Our Validation Team consists of over 20 highly trained experts with years of experience in computerized systems validation, work in pharma or medical devices factories, supporting clinical trials, warehouse areas and many more, which brings a crucial advantage in understanding the client's processes and expectations. The Validation Team supports clients with all types of validation activities, on all the stages of computerized system lifecycle, from implementation phase, operations till the disposal of Computerized system.
Senior Validation SpecialistNumer ref.: APD/CSV/remote/10
- Determine validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerized systems;
Be responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance;
Authorize validation plans/reports, reviews test plans/reports (and other deliverables) to assess and notify that the system is ready to go life;
Verify testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions according to approved procedures;
Support system audit/inspection preparation and execution as CSV subject matter expert.
Support system maintenance with validated state and permanent audit readiness;
Implements relevant framework and processes, propose and uses tools.
4+ years of experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment including:
Leading validation for projects and systems maintenance;
Authoring validation plans, reports and deliverable registries;
Authoring or reviewing validation related deliverables, records and other evidences;
Maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11;
Ability to work collaboratively in cross-functional teams to achieve milestones and goals;
Communication skills, English language mandatory (C1).
Please include in your application the following consent:
I agree to the processing of my personal data provided by me, not mentioned in art. 221 § 1 of the Labor Code, or other specific provisions applicable pursuant to art. 221 § 4 of the Polish Labour Code, in order to recruit by the Administrator - Avenga IT Professionals Sp. z o.o. with registered office in Wrocław, ul. Gwiaździsta 66, 53-413 Wrocław, for the position of Senior Python Developer.