Supplier Specialist ( External Manufacturing - Pharma

Supplier QA Specialist (QA External Manufacturing) - Pharma

Mid-Senior level Not discloses Italy Milan, Lombardy, Italy

186 days ago

Jefferson Wells is looking for a Supplier QA Specialist (QA External Manufacturing) on behalf of an company operating in the pharmaceutical field. The resource 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.

• Supplier
  
  Qualification:
  
  
  • 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.

• It would be preferable for the resource to have the QP certification or, in its absence, the necessary requirements for the acquisition.
• Education:
  
  Master degree in Pharmacy, Chemistry, or a related scientific discipline.
• Experience:
  
  Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry, with a focus on auditing.
• Knowledge:
  Strong knowledge of GMP regulations, quality systems, and auditing principles.
• Skills:
  
  Excellent communication, interpersonal, and problem-solving skills. Proficient in written and spoken English.