CSV lead

CSV Lead

Location:

San Francisco, CA, United States

Contract

Technical

Skills Required:

• Computer System Validation
• Life cycle
• Process Validation
• Risk Assessment
• FDA standards
• Test Planning
• Corrective Action Plan
• Experience in CSV for equipment Domain:
  Biotechnology

Project Management skills and Team handling would be preferred

Non-Technical Requirements:

• Communication Skill
• Location Preference
• In-Tangible skill requirement

Required Experience:

• 8+ years of experience in CSV Implementation with at least few equipment validation experience
• Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
• Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan
• Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
• Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
• Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
• Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel
• Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems
• Responsible for review & verification of Corrective Action Plan for audits
• Perform periodic review/monitoring of computer systems implemented
• Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process