QA External Manufacturing

Job title:

Antal International

Job DescriptionThe Company:Multinational pharmaceutical company is looking for a:QA External Manufacturing & Food SupplementsThe 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