QA Lead: Change Control & CSV for Pharma

Veg Group; Guaynabo (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Quality Assurance Specialist to provide independent QA oversight of Change Control, Qualification, and CSV activities in a GMP environment.

The role emphasizes documenting decisions, maintaining traceability, and escalating risks to management. The candidate will coordinate cross-functional QA activities, ensure compliance with FDA cGMP and EU guidelines where applicable, and support the creation of executive dashboards and QA metrics for

Qualifications

• 3+ years QA experience in GMP-regulated life sciences environments.
• Experience reviewing Change Control and CSV lifecycle documents.
• Reviewing qualification or CSV lifecycle documents and protocols.
• Strong understanding of GMP regulations, GDP, data integrity, and 21 CFR Part 11/GAMP principles.
• Ability to identify compliance risks and escalate issues to management.

Responsibilities

• Provide independent QA oversight for Change Control, Qualification, and CSV activities.
• Review and approve records with clear, actionable comments; ensure traceability and compliance.
• Coordinate Change Control program and lead the Change Control Committee sessions.
• Govern qualification decisions; review documentation and assess system impact and acceptance criteria.
• Oversee CSV documentation, validation plans, and release criteria across validated systems.
• Maintain inspection-ready records and dashboards to track actions, risks, and milestones.

Skills

Change Control

CSV

GMP Knowledge

Data Integrity

Risk-based Qualification

Documentation

English Communication

Spanish Preferred

GxP Knowledge

Education

Bachelor's degree in science/engineering/quality

Tools

Electronic Quality Management System (eQMS)

Electronic approvals workflows

Job description

Validation & Engineering Group, Inc. is seeking a Quality Assurance Specialist to provide independent QA oversight of Change Control, Qualification, and CSV activities in a GMP environment.

The role emphasizes documenting decisions, maintaining traceability, and escalating risks to management. The candidate will coordinate cross-functional QA activities, ensure compliance with FDA cGMP and EU guidelines where applicable, and support the creation of executive dashboards and QA metrics for