Senior CSV Lead for GxP Validation & Compliance

TechDigital Group; New Jersey; On-site; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking a seasoned professional with over a decade of experience in Computer System Validation and GxP compliance. This role involves validating systems and ensuring adherence to regulatory standards, particularly in the life sciences sector. The successful candidate will manage risk assessments, document processes, and lead validation efforts using Agile and Waterfall methodologies. This position offers an opportunity to collaborate with regional stakeholders and enhance service quality while driving customer satisfaction in a dynamic environment. If you are passionate about compliance and system assurance, this is the perfect role for you.

Qualifications

• 10+ years of experience in Validating systems and CSV activities.
• Adept in GxP applications and compliance analysis.

Responsibilities

• Ensure compliance with regulatory requirements for GxP systems.
• Review and author Validation Plans and compile Validation Summary Reports.

Skills

CSV Validation

GxP Compliance

Risk Assessment

Agile Methodology

Waterfall Methodology

Defect Tracking

Documentation Skills

Education

Bachelor's Degree in Life Sciences or related field

Tools

Veeva

Argus

JIRA

ALM

DMS

Job description

An established industry player is seeking a seasoned professional with over a decade of experience in Computer System Validation and GxP compliance. This role involves validating systems and ensuring adherence to regulatory standards, particularly in the life sciences sector. The successful candidate will manage risk assessments, document processes, and lead validation efforts using Agile and Waterfall methodologies. This position offers an opportunity to collaborate with regional stakeholders and enhance service quality while driving customer satisfaction in a dynamic environment. If you are passionate about compliance and system assurance, this is the perfect role for you.