Avenga is a global IT and digital transformation champion. We deliver strategy, customer experience, solution engineering, managed services, software products and outsourcing services like: staff augmentation, team leasing and permanent employment.
Together, we are more than 2500 professionals with over 20 years of experience. We are present in Europe, Asia and the USA.
Senior CSV Consultant
Miejsce pracy: Gdańsk
Nr ref.: /APD/CSV/remote/01
Nr ref.: /APD/CSV/remote/01
Responsibilities
- 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.
Requirements
- 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).