QA External Manufacturing

Antal International Network; Milano; In loco; Riservato; Tempo pieno

Descrizione del lavoro

A leading multinational pharmaceutical company is seeking a QA External Manufacturing & Food Supplements professional in Milan. The role involves ensuring quality compliance of pharmaceutical products, conducting audits, and collaborating with suppliers to maintain high standards. Ideal candidates will have a Master's degree in Pharmacy or Chemistry and significant experience in Quality Assurance within the pharmaceutical industry.

Competenze

• At least 5 years of experience in Quality Assurance within the pharmaceutical industry.
• Strong knowledge of GMP regulations and auditing principles.

Mansioni

• Ensure the quality and compliance of purchased pharmaceutical products.
• Conduct supplier audits and maintain supplier qualification documentation.
• Collaborate with Regulatory Affairs for compliance of purchased products.

Conoscenze

Communication

Problem Solving

Attention to Detail

Organizational Skills

Formazione

Master’s degree in Pharmacy

Master’s degree in Chemistry

Descrizione del lavoro

The Company:

Multinational pharmaceutical company is looking for a:

QA External Manufacturing & Food Supplements

The Role:

• Ensure the quality and compliance of purchased pharmaceutical products, including raw materials, finished drug products, food supplements, and medical devices
• Collaborate with suppliers, Contract Manufacturing Organizations (CMOs), and internal departments to ensure adherence to GMP, regulations, and company quality standards
• Evaluate and qualify 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
• Review and approve supplier documentation, including specifications, certificates of analysis, production batch records, 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
• 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
• Plan and conduct audits of CMOs and other GMP service suppliers, prepare audit reports, and follow up on corrective actions
• Collaborate with Regulatory Affairs to ensure compliance of purchased products with applicable regulations and provide quality input for product registrations and variations
• Stay up to date with changes in relevant regulations and guidelines

Requirements:

• Master’s degree in Pharmacy, Chemistry, or a related scientific discipline
• At least 5 years of experience in Quality Assurance within the pharmaceutical industry, with a focus on auditing
• Strong knowledge of GMP regulations, quality systems, and auditing principles
• Familiarity with relevant regulations for pharmaceuticals, food supplements, and medical devices
• Excellent communication, interpersonal, and problem-solving skills
• Proficiency in written and spoken English
• Strong attention to detail, organizational skills, and ability to work independently and in a team

Work area:

Milan