QA External Manufacturing & Food Supplements

Jefferson Wells; Milano; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking a QA External Manufacturing professional in Milano. This critical role involves ensuring the quality and compliance of products through supplier audits and adherence to Good Manufacturing Practices (GMP). Candidates should have a solid background in quality assurance and supplier evaluations, contributing to the company's commitment to quality standards.

Competenze

• Experience in Quality Assurance in the pharmaceutical industry.
• Familiarity with supplier qualification processes and GMP compliance.
• Strong analytical and problem-solving skills.

Mansioni

• Evaluate and qualify suppliers of pharmaceutical products.
• Conduct supplier audits to ensure compliance with GMP.
• Collaborate with Regulatory Affairs for product registration compliance.

Conoscenze

Quality Assurance

Good Manufacturing Practices (GMP)

Supplier Audits

Regulatory Compliance

Descrizione del lavoro

The QA External Manufacturing & Food Supplements, will play a critical role in ensuring the quality and compliance of purchased pharmaceutical products, including raw materials, finished drug products, food supplements and medical devices. This role will involve close collaboration with suppliers, Contract Manufacturing Organizations (CMOs), and internal departments to ensure adherence to Good Manufacturing Practices (GMP), relevant regulations, and company quality standards.

Key Responsibilities :

Evaluate and qualify potential suppliers of pharmaceutical products, raw materials, packaging components and GMP services.

• Conduct supplier audits, both on-site and remotely, to assess compliance with GMP and quality standards.
• Maintain and update supplier qualification documentation.
• Purchased Product Quality :

Review and approve supplier documentation, including specifications, certificates of analysis, production batch record, and change notifications.

• Oversee the inspection and release of incoming purchased products.
• Manage supplier non-conformances, deviations, and complaints.
• Implement and maintain quality agreements with suppliers.
• Ensure compliance of purchased products with relevant GMP regulations and guidelines.
• GMP Compliance :

Support internal departments in the investigation and resolution of quality issues related to purchased products.

• Contribute to the maintenance of the company's quality management system.
• Audits :

Plan and conduct audits of CMOs and other suppliers of GMP services.

• Prepare audit reports and follow up on corrective actions.
• Support internal and external audits as required.
• Regulatory Interface :

Collaborate with Regulatory Affairs to ensure compliance of purchased products with applicable regulations.

• Provide quality input for product registrations and variations.
• Stay abreast of changes in relevant regulations and guidelines.

External Manufacturing • MILANO, Lombardia