Lavori attuali relativi a Computerised System Validation Specialist - Parma, Emilia-Romagna - Data Rover
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Computerised System Validation Specialist
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Computerised System Validation Specialist
2 mesi fa
We are seeking a skilled Computerised System Validation Specialist to join our team at Data Rover. As a CSV Specialist, you will be responsible for managing the design and execution of tests, providing client support in software system validation, and developing validation plans.
Responsibilities:
* Independently manage the design and execution of tests
* Provide client support in software system validation
* Develop validation plans, conduct tests, collect and evaluate results, and prepare validation reports
* Define and write Validation Plans, Validation Reports, Test plans, Acceptance tests, User Requirements, etc.
* Manage Change Control and Periodic Review processes
* Conduct Data Integrity Assessments
* Write and review Standard Operating Procedures and Work Instructions
* Draft Design and Functional Specification documents in cooperation with our System or Process Engineers and manage formal revision and approval processes
* Write and execute IQ/OQ/PQ test protocols for computer systems, processes, equipment, and utilities
* Perform Technical Impact Assessments
* Write and review Calibration and Maintenance Plans
* IT/OT Infrastructure Qualification plan, tests, and procedures writing and review
Requirements:
* Very good knowledge of pharma standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc.)
* Language skills: Italian and English CEFR C1 level or higher (read, written, and spoken)
* Utmost professionalism and seriousness towards customers and colleagues
What We Offer:
* Internal and external training programs
* Performance bonuses
* Overtime pay in compliance with regulations
* Team building activities
At Data Rover, we value differences and welcome people from all walks of life. We believe in equal opportunities for everyone and apply fair working conditions and salaries related to assigned responsibilities, skills, and personal merit.
A salary pack that matches your responsibilities, a growth plan, and attractive bonuses based on results.
Internal and external trainings specifically selected based on your aptitudes and talent. A set of benefits, services, and affiliations on top of the profession's health insurance.
We're a company of human beings, before anything else. You'll never be \"just a number\" here.
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