QA External Manufacturing

The Company:

Multinational pharmaceutical company is looking for a:

QA External Manufacturing - Sterile & 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
• Holds the Qualified Person (QP) qualification, or meets the eligibility criteria for its attainment
• Proven experience in sterile manufacturing environments and thorough understanding of associated GMP requirements
• Sound knowledge of food supplements regulations and production processes
• 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