Quality Assurance Manager

Alfasigma S.p.A.; Mexico; Sur place; PHP 3 701 418 - 5 552 127; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

ISO-9000

Formation

Bachelor level in Pharmacy or related field

Pharmaceutical Engineer

Industrial Pharmaceutical Chemist

Pharmaceutical Chemist Biologist

Description du poste

Responsabilities:

• Verify that the company's legal records are up-to-date and attend to visits made by authorities to the assigned facilities.
• Develop and authorize the company's 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.

Experience:

• At least 3 years of experience in the same role or as Sanitary Manager
• Education: Pharmaceutical Chemist Biologist, Industrial Pharmaceutical Chemist, Pharmaceutical Engineer, Bachelor of Pharmacy or related field (with degree)

Skills:

• ISO-9000

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success. We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.