Computer System Validation Lead

Computer System Validation Lead

Location:

Sunnyvale, CA

Duration:
Contract (6+ months)

Job Category:
Quality Assurance

Job Description:

Mandatory Skill:

(List out all Technical Skills required along with domain skill required)

• Computer System Validation.
• Life cycle.
• Process Validation.
• Risk Assessment.
• FDA standards.
• Test Planning.
• Corrective Action Plan.
• Experience in CSV for ERP –JDE 9.1 Implementations
• CSV/21
  
  CFRPart
  11/GxP

Other

Skills:

• Project Management skills and Team handling would be preferred.
• 8+ years of experience in CSV Implementation.
• Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
• 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.
• 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.

Education

Qualification:

Master's Degree/Bachelor's Degree.

Key

Skills:

Computer System Validation, Life cycle, Process Validation, Risk Assessment, FDA standards, Test Planning, Corrective Action Plan.