CSV Analyst

Role & responsibilities

• Writes, reviews, supports and executes all system lifecycle documents (URS, Validation Plan, Specifications, Risk Assessment, Qualifications IQ/OQ/PQ, Data Integrity Evaluations, Trace Matrix, SOPs, Validation Summary Report, etc.).
• Work closely with project stakeholders (IT, System Owner, QA, Cyber Security) to effectively and efficiently implement new systems, system upgrades, or system modifications.
• Writes and Reviews Operational SOPs and Processes
• Gather and control Software and Hardware Inventory lists.
• Develops and manages project schedules to drive efficient projects executions.
• Manages consultants to ensure that project timeline, budget, and quality are maintained
• Manages CSV projects under a GAMP lifecycle framework.
• Conducts data integrity and information assurance evaluations and enforces the required controls.
• Supports client and regulatory audit activities.
• Assist in development, implementation, and enforcement of computer system validation, information assurance, cyber security, and data integrity policies and practices.
• Perform periodic reviews of the validated computerized systems.
• Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
• Work closely with cyber security team
• Performs routine backup analysis and trending
• Perform Infrastructure Qualifications
• Perform Data integrity Reviews
• Perform Excel validation
• Perform other duties as assigned.

Preferred candidate profile

• At least 1-3 years of Computer System Validation experience required. Experience in pharmaceutical industry is preferred.
• Minimum BA / BS or relevant work experience in information systems, information assurance, Analyzing, science or business.
• 1-3 years of experience writing, reviewing and executing computer validation documentation
• Basic understanding of computer networks, protocols, operating systems, as well general information and operational technology stacks.
• Basic understanding of information assurance and cyber security. Experience in disaster recovery, identity and access management, asset management, patch and vulnerability management, and cyber incident response preferred.
• Experience in Data integrity Reviews, Excel validation or infrastructure validation
• Thorough understanding of the principles of computer systems validation, system development lifecycle (SDLC) methodologies and testing best practices.
• Knowledge of cGMP, GDP, GAMP, 21CFR Part11, ALCOA+, and NIST CSF and other industry best practices.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Strong communication and interpersonal skills
• Excellent oral and written communication skills.

Perks and benefits