Quality Validation Engineer II — On‑Site Puerto Rico

Medial Group; Villalba (PR); In loco; USD 55.000 - 85.000; Tempo pieno

Descrizione del lavoro

Medial Group is seeking a Quality Validation Specialist to ensure compliant validation of quality IT systems in a regulated environment. The role involves documenting procedures, coordinating with clients and developers, and ensuring regulatory alignment across domestic and global operations.

You will validate computerized systems, report on validation progress, manage non-conformances, and drive CAPA activities to closure.

Competenze

• Minimum 2 years of relevant experience in the regulated industry.
• Knowledge of Good Manufacturing Practices (GMP).
• Good problem-solving skills and attention to detail.

Mansioni

• Conducts a compliant validation process for quality IT systems with required documentation.
• Coordinates activities with clients, developers, and operating personnel, domestically and globally.
• Identifies requirements for compliant computerized operations and maintains procedures and records.
• Reports on validation status to meet regulatory requirements.
• Performs system administration and configuration of quality IT systems.
• Investigates non-conformances and initiates CAPA actions.
• Leads complaint activities with Operating Units and ensures corrective actions are completed.

Conoscenze

Quality Assurance

GMP Knowledge

Problem Solving

Documentation

Overtime Availability

Descrizione del lavoro

Medial Group is seeking a Quality Validation Specialist to ensure compliant validation of quality IT systems in a regulated environment. The role involves documenting procedures, coordinating with clients and developers, and ensuring regulatory alignment across domestic and global operations.

You will validate computerized systems, report on validation progress, manage non-conformances, and drive CAPA activities to closure.