Data Integrity / CSV Specialist - 176853

Qualifications

• Bachelor's or Master's degree in a scientific, engineering, computer science, or related discipline; equivalent experience may be considered.
• 3+ years of experience in the pharmaceutical, biotechnology, or other highly regulated industry.
• Hands-on experience with Data Integrity and Computerized System Validation (CSV) in a GMP environment.
• Strong understanding of 21 CFR Part 11, 21 CFR Parts 210/211, GAMP 5, and Data Integrity principles.
• Required: Knowledge and practical experience with EU GMP Annex 11.
• Experience performing Data Flow Mapping, risk assessments, gap assessments, and/or Data Integrity remediation activities.
• Strong understanding of ALCOA+ principles and good documentation practices.

Responsibilities

• Support Data Integrity assessments and initiatives across various site functions.
• Lead and support Data Process Flow Mapping as a primary focus.
• Conduct Data Integrity gap assessments, risk assessments, and compliance reviews for computerized systems.
• Perform onsite periodic reviews to identify data integrity risks and remediation opportunities.
• Provide guidance to SMEs and stakeholders on Data Integrity, CSV, and cGMP compliance requirements.
• Support development and execution of Data Integrity remediation plans and track activities.
• Perform Data Quality Reviews to identify potential data integrity concerns.

Benefits

• Onsite work environment fostering collaboration with cross-functional teams.
• Long-term engagement through 2027, providing job stability.
• Opportunity to work in a highly regulated industry, enhancing professional expertise.
• Engagement in critical compliance and quality assurance activities.