Quality Assurance Lead: GMP, Audits & Compliance

Ups; Ciudad de México; Presencial; MXN 450.000 - 650.000; Jornada completa

Descripción de la vacante

UPS is seeking a Quality Assurance professional in Mexico City to monitor the overall Quality System status of the distribution center, ensuring compliance with drug, medical device, and local regulations.

The role involves training staff in GMP, maintaining SOPs, conducting inspections, and coordinating corrective actions. QPIC duties and regulatory audits with Health Canada may be included, along with continuous improvements of Quality Systems.

Formación

• Quality Assurance experience preferred.
• GMP knowledge preferred.
• Bachelor’s Degree in Science related field or internationally comparable degree preferred.
• QPIC/AQPIC designation preferred.

Responsabilidades

• Ensures all staff is trained in their respective job functions, including GMP.
• Writes and revises Standard Operating Procedures as required.
• Conducts regular inspections of the facility and recordkeeping, including summarization and reporting of findings.
• Coordinate or assist with corrective actions and preventative measures.
• Communicates with clients and provides information during external audits; liaises with Health Canada officials during regulatory audits.
• Provides feedback and assistance to Customer/Client QA related questions and concerns.
• Monitors the processes and systems within the Department to ensure regulatory compliance and effective operation.
• Investigates discrepancies and problems, and advises the appropriate individuals of the findings.
• Assists in development of pro-active strategies as a preemptive measure against potential future problems with systems or processes.
• Completes NCR reports and change control requests and provide necessary follow-up.
• Performs maintenance, support, and continuous improvements of Quality Systems.
• QPIC designation duties.

Conocimientos

Quality Assurance

GMP

Regulatory compliance

Educación

Bachelor’s Degree in Science related field

Descripción del empleo

UPS is seeking a Quality Assurance professional in Mexico City to monitor the overall Quality System status of the distribution center, ensuring compliance with drug, medical device, and local regulations.

The role involves training staff in GMP, maintaining SOPs, conducting inspections, and coordinating corrective actions. QPIC duties and regulatory audits with Health Canada may be included, along with continuous improvements of Quality Systems.