Requirements: English
Company: Antal International
Region: Milan , Lombardy
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 companys 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:
- Masters 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
- 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