QA & Compliance Manager (ISO 9001, Audits, CAPAs)

Alfasigma; Ciudad de México; On-site; MXN 360,000 - 480,000; Full time

Job summary

Alfasigma in Ciudad de México seeks a QA/Quality Assurance professional to verify records and ensure compliance with ISO 9001, develop and approve procedures, and conduct audits. The role includes managing CAPAs and guiding the company to maintain a compliant QMS.

The candidate should have a pharmaceutical degree and at least 3 years in the same role, with strong regulatory knowledge and training program experience.

Qualifications

• 3+ years of experience in the same role
• Education in Pharmaceutical fields as listed
• Experience with ISO 9001 quality management system and regulatory compliance

Responsibilities

• Verify company records and respond to authority visits.
• Develop and authorize technical/operational procedures; ensure compliance.
• Perform supplier and internal audits as scheduled and in compliance with regulations.
• Verify and implement annual document management system training for personnel.
• Close complaints, deviations, and CAPAs per procedures.
• Maintain ISO 9001 QMS compliance across the company.
• Guide all areas to keep the QMS up-to-date and compliant.

Skills

Quality management

Audits

Regulatory compliance

CAPA handling

Education

Pharmaceutical degree

Bachelor of Pharmacy or related field

Job description

Alfasigma in Ciudad de México seeks a QA/Quality Assurance professional to verify records and ensure compliance with ISO 9001, develop and approve procedures, and conduct audits. The role includes managing CAPAs and guiding the company to maintain a compliant QMS.

The candidate should have a pharmaceutical degree and at least 3 years in the same role, with strong regulatory knowledge and training program experience.