Qa External Manufacturing

Whatjobs; Milano; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A multinational pharmaceutical company in Milan is looking for a Quality Assurance External Manufacturing specialist. This role involves ensuring the quality of pharmaceutical products and food supplements, conducting supplier audits, and maintaining compliance with GMP regulations. The ideal candidate has a Master’s degree and at least 5 years of experience in Quality Assurance within the pharmaceutical industry, preferably with sterile manufacturing experience.

Competenze

• 5+ years of experience in Quality Assurance in the pharmaceutical industry, focusing on auditing.
• Holds or eligible for Qualified Person (QP) qualification.
• Experience in sterile manufacturing environments and understanding of GMP requirements.

Mansioni

• Ensure quality and compliance of pharmaceutical products and food supplements.
• Collaborate with suppliers and internal departments to meet GMP and quality standards.
• Conduct supplier audits to assess compliance.

Conoscenze

Quality Assurance

Communication

Problem-solving

Attention to detail

Organizational skills

Formazione

Master’s degree in Pharmacy, Chemistry, or related field

Descrizione del lavoro

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