Quality Assurance Expert

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

Descrizione del lavoro

A multinational pharmaceutical company is seeking a Quality Assurance Specialist to ensure the quality and compliance of various purchased products, including pharmaceuticals and medical devices. The role involves supplier evaluations, audits, and collaboration with Regulatory Affairs, requiring a Master's degree in Pharmacy and extensive experience in the field.

Competenze

• 5+ years of experience in Quality Assurance within the pharmaceutical industry.
• Qualified Person (QP) qualification or eligibility for its attainment.
• Experience in sterile manufacturing environments with knowledge of GMP requirements.

Mansioni

• Evaluate and qualify suppliers for pharmaceutical products including raw materials.
• Conduct audits to assess compliance with GMP and quality standards.
• Maintain the quality management system and documentation.

Conoscenze

Quality Assurance

Auditing

Problem-Solving

Communication

Attention to Detail

Formazione

Master's degree in Pharmacy

Master's degree in Chemistry

Descrizione del lavoro

We are seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the quality and compliance of purchased pharmaceutical products, including raw materials, finished drug products, food supplements, and medical devices.

Main Responsibilities :

• 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

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
• Solid 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

About Us :

A multinational pharmaceutical company is looking for a Quality Assurance Specialist.