Audit Specialist Supplier Quality Department

JR Italy; Trento; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking an Audit Specialist to enhance the integrity of its global supply chain. This role involves leading GMP audits, evaluating supplier performance, and driving continuous improvement initiatives. You will play a vital role in ensuring compliance and enhancing product excellence, making a significant impact on patient safety. Join a dynamic team where your expertise will contribute to maintaining high-quality standards and regulatory compliance across various operations. If you are passionate about quality and compliance, this is the perfect opportunity for you!

Competenze

• Degree level qualification in science or engineering discipline.
• 2-3 years experience in auditing pharmaceutical companies.
• Experience in quality system management.

Mansioni

• Conduct audits for Third Party Manufacturing and Analytical Laboratories.
• Support Quality Agreements and maintain Quality Corporate Policies.
• Travel domestically and internationally for audits.

Conoscenze

Proactive approach

Team collaboration

Project management

Continuous improvement mindset

Independent task completion

Documentation skills

Regulatory guidance interpretation

Knowledge of pharmaceutical regulations

Communication skills in English

Formazione

Degree in Science or Engineering

Experience in auditing pharmaceutical companies

Experience in GDP area

Strumenti

Electronic Quality Management System (Veeva, Trackwise)

Descrizione del lavoro

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Audit Specialist Supplier Quality Department, trento

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Client:

Alfasigma

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

2746833127132364800337123

Job Views:

1

Posted:

07.05.2025

Expiry Date:

21.06.2025

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Job Description:

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 and join our team!

Key responsibilities:

• Perform the audits to Third Party Manufacturing, Secondary Packaging, API and Excipient Manufacturing, Analytical Laboratories Suppliers according to an Audit Plan (scheduling, agenda, audit reports and CAPA monitoring); sterile and non-sterile products, medical devices
• Domestic and International travel is expected to conduct audits
• Support and provide input to Quality Agreements with suppliers
• Enforcement and support implementation/improvement of existing Quality Systems and processes to ensure continuously appropriate/compliant execution of operations and processes internally and with external suppliers
• Support the maintenance of Quality Corporate Policies and Procedures and the implementation of the new issued/updated guidelines/regulations inside the Company
• Support Supplier Quality and Local Quality Teams in case of audit from Regulatory Agencies and Customers
• Other project duties as assigned supporting company products and processes

The candidate should have the following skills:

• Be proactive
• Strong ability to work in multi-department teams
• Strong ability to manage specific projects, interacting with internal and external members
• A natural tendency towards continuous improvement
• Ability to complete tasks independently and with minimal oversight
• Excellent documentation skills and proficiency in typical office computer programs and use of an electronic Quality Management System (ex: Veeva, Trackwise or similar EQMS tools)
• Ability to interpret regulatory guidance, company policies and procedures into executable and defendable lifecycle documentation
• Understanding of modern and risk based validation executions
• Deep Knowledge of the Regulations applicable for pharmaceutical products in the major markets (EU, US)
• Good communications and written skills in English

The following Educational and Experience Requirements are expected:

• Degree level qualification, science or engineering discipline
• Significant experience (at least 2-3 years) in auditing department of pharmaceutical company, both for APIs & CMOs (medical device and food supplement experience a plus).
• Significant experience (at least 2-3 years) in GDP area
• Consolidated experience in quality system management (QMS)
• Previous experience in quality control laboratories and/or production areas will be favorably considered

Company:

Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.

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