ISO 9001 QA & Compliance Manager — Audits & CAPAs

Alfasigma S.p.A.

Mexico

Hybrid

PHP 3,701,418 - 5,552,127

Full time

14 days+

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Job summary

Alfasigma S.p.A. is seeking a Sanitary/QA Manager to lead the quality management program and ensure regulatory compliance across facilities. You will develop procedures, oversee audits, and drive CAPA closure while maintaining ISO 9001 standards.

The role requires at least 3 years in a related function and a strong background in pharmaceutical regulations, with a degree in pharmacy or related field. This on-site position offers growth and competitive compensation.

Qualifications

ISO 9001 quality management experience or certification.
Experience with audits and CAPA processes.
Strong understanding of regulatory requirements for pharmaceutical operations.
Ability to develop and implement technical and operational procedures.

Responsibilities

Verify that the company's legal records are up-to-date and attend to visits by authorities.
Develop and authorize technical and operational procedures, as well as ensure compliance with these procedures and the warehouse's technical documentation.
Conduct and execute supplier and internal audits on time and in accordance with regulations.
Verify and implement the annual document management system training program for company personnel through training.
Follow up on and close complaints, deviations, and CAPAs (Conformities, Approvals, and Action Plans) generated according to established procedures.
Maintain compliance with the ISO 9001 quality management system within the company.
Provide guidance to all areas of the company to ensure the quality management system remains up-to-date and compliant with current regulations.