QA External Manufacturing

Antal International; Milano; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading multinational pharmaceutical company is seeking a QA External Manufacturing professional based in Milan. The successful candidate will ensure the quality and compliance of pharmaceutical products and food supplements, requiring a Master’s degree and extensive QA experience. Responsibilities include supplier audits and maintaining quality agreements.

Competenze

• 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.
• Proven experience in sterile manufacturing environments and understanding of GMP requirements.

Mansioni

• Ensure compliance of purchased pharmaceutical products and raw materials with GMP standards.
• Conduct supplier audits to assess compliance with quality standards.
• Collaborate with Regulatory Affairs to ensure compliance with applicable regulations.

Conoscenze

Auditing

Quality Assurance

Regulatory Compliance

Communication

Problem Solving

Formazione

Master’s degree in Pharmacy

Master’s degree in Chemistry

Descrizione del lavoro

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

Qa External Manufacturing • Via Milano, Italia