Csv Specialist I (Entry - Level)

• Read, understand and follow the standards operating procedures for the Computerized System Life Cycle documentation and process.
• Reviews, understands and makes suggestions into the Computer System Validation (CSV) lifecycle documentation.
• Read and understand protocol tests scripts and organize the preparation activities for protocol test execution.
• Communicate with personnel or areas that can be affected during validation activities by overseeing and reviewing areas, processes, and procedures related to the system to be validated.
• Perform protocol test scripts execution, documentation and closures including description, root cause and corrective actions of any deviations found during the execution.
• Reviews and executes qualification protocols and performs related tasks, including supports the protocol closure and validation summary plan and report activities.
• Acts as a team member to collaborate with colleagues on tasks assigned by SMEs, leaders or managers.
• Notify through written communications to leaders or managers of any discrepancy found between qualification protocols and specifications requirements.
• Understand base systems and information technology terminologies into GAMP principles and framework, and software application/platforms and services.
• Provide training to end-users on system operation and standards procedures.
• Execute systems development lifecycle documentation for validation, including In-House testing, FAT, SAT, IQ, OQ and PQ.
• Create, review and revise specifications and requirements, including system development and coding phase, functionality, safety, security, hardware, software, performance and data integrity among others
• Plan, define and create verification tests scripts strategies and documentation of qualification protocol for the validation of low and medium-risk criticality level systems.
• Collaborate with project teams to prepare and revise systems development lifecycle documentation for validation, including In-House Testing, FAT, SAT, IQ, OQ, PQ and TM of low and medium-risk criticality level systems.

• Bachelor's degree in Engineering, Sciences, or a related field.
• Up to 2 years' experience is required in computer system validation, quality assurance, or regulatory compliance within a regulated industry. Relevant internships, co-op placements, or coursework can be considered.
• Exposure to and basic understanding of CSV processes and regulatory requirements.
• Familiarity with protocol test scripts and validation documentation.
• Basic knowledge of IT systems and software applications.
• Experience with standard operating procedures (SOPs) and compliance documentation.
• Proficiency in computer programs: Microsoft Office (Word, Excel).
• Understanding of the Computerized System Life Cycle (CSLC) and GAMP principles.
• Knowledge of validation activities such as FAT, SAT, IQ, OQ, and PQ.
• Ability to review and provide input on CSV lifecycle documentation.
• Proficiency in creating, reviewing, and revising specifications and requirements.
• Ability to execute and document protocol test scripts and handle deviations.
• Familiarity with verification test scripts strategies for low and medium-risk systems.
• Strong analytical and problem-solving skills.
• Fluency in English and Spanish languages (written/spoken).

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