Audit Specialist Supplier Quality Department

Audit Specialist - Supplier Quality Department

Are you passionate about quality and compliance? Step into a critical role where your expertise ensures the integrity of our global supply chain.

As an Audit Specialist in our Supplier Quality Department, you'll lead GMP audits, evaluate supplier performance, and drive continuous improvement across our sourcing operations. Make a real impact on patient safety and product excellence by joining our team!

Key responsibilities:

• Perform audits of Third Party Manufacturing, Secondary Packaging, API and Excipient Manufacturing, Analytical Laboratories Suppliers, and medical devices according to an Audit Plan (scheduling, agenda, audit reports, and CAPA monitoring); including sterile and non-sterile products.
• Travel domestically and internationally to conduct audits.
• Support and provide input for Quality Agreements with suppliers.
• Enforce and support the implementation/improvement of existing Quality Systems and processes to ensure compliant operations internally and with external suppliers.
• Assist in maintaining Quality Corporate Policies and Procedures, and implement new or updated guidelines/regulations within the company.
• Support Supplier Quality and Local Quality Teams during audits from Regulatory Agencies and Customers.
• Perform other project duties as assigned to support company products and processes.

Candidate skills:

• Proactive attitude.
• Strong teamwork skills across departments.
• Project management abilities, with effective interaction with internal and external stakeholders.
• Continuous improvement mindset.
• Ability to work independently with minimal oversight.
• Excellent documentation skills and proficiency with office software and electronic Quality Management Systems (e.g., Veeva, Trackwise).
• Ability to interpret regulatory guidance, company policies, and procedures into executable documentation.
• Understanding of modern, risk-based validation processes.
• Deep knowledge of pharmaceutical regulations in major markets (EU, US).
• Good communication and written skills in English.

Educational and experience requirements:

• Degree in science or engineering.
• At least 2-3 years of experience in pharmaceutical auditing, including API & CMO audits (experience with medical devices and food supplements is a plus).
• Experience in GDP areas.
• Solid background in quality system management (QMS).
• Previous experience in quality control laboratories or production areas is advantageous.

About Alfasigma: A global pharmaceutical company founded over 75 years ago in Italy, with operations in over 100 markets worldwide. We focus on research, development, production, and distribution of medicinal products across therapeutic areas such as Gastroenterology, Vascular, and Rheumatology, dedicated to improving health and quality of life.