SHEQ Manager & Qualified Person

Posted 24 Days Ago
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Via Arese, Milan
In-Office
Senior level
Biotech
The Role
The SHEQ Manager will lead the SHEQ function, ensuring compliance with standards and serving as Qualified Person for APIs. Responsibilities include managing quality assurance, audits, supplier qualifications, and training programs.
Summary Generated by Built In

We are looking for a SHEQ Manager & Qualified Person (QP) who will lead the SHEQ function in Azelis Italy and ensure compliance with regulatory, quality and corporate standards. The role also includes serving as the Qualified Person for imported Active Pharmaceutical Ingredients (APIs) in accordance with EU GMP requirements.

Key Responsibilities

  • Lead and maintain the SHEQ Management System, ensuring compliance with local regulations, ISO standards and internal policies.

  • Oversee product quality assurance activities, including managing non-conformities, customer quality requests, supplier documentation and corrective actions.

  • Coordinate internal and external audits and monitor the effectiveness of improvement actions.

  • Support supplier qualification, evaluation and continuous improvement processes.

  • Ensure that product specifications, certificates and quality documentation are accurate and up to date.

  • Plan and deliver training and awareness programs related to SHEQ

  • Collaborate with commercial, logistics and operational teams to maintain consistent SHEQ performance across the business.

  • Act as Qualified Person (QP) for imported APIs, ensuring compliance with applicable GMP/GDP regulations, batch certification principles and proper documentation standards.

Qualifications & Experience

  • Degree in relevant scientific discipline (required for QP eligibility).

  • Eligibility to act as a Qualified Person under EU Directive 2001/83/EC.

  • Experience in Quality Assurance, GMP/GDP, and SHEQ roles, ideally in the pharmaceutical or chemical sector.

  • Strong knowledge of regulatory frameworks, GMP, GDP, and ISO standards.

  • Excellent communication, analytical, and stakeholder management skills.

  • Strong command of English

Top Skills

Gdp
Gmp
Iso Standards
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The Company
Berchem
2,676 Employees

What We Do

As a leading global innovation service provider in the specialty chemicals and food ingredients industry, we are committed to creating value for principals and customers whilst providing a great work environment and career opportunities.

Azelis has 4,200+ employees across 65 countries worldwide. We work with around 2,800 principals to provide a diverse range of innovative products/services to 63,000+ customers.

Our industry-dedicated sales teams have specialist product and application knowledge, combined with business know-how, enabling us to add value in all business relationships.

We’re always looking to add new talent to our team and encourage and support the personal and professional growth of all employees.

Specialties include:

Life Sciences: Personal Care, Home Care & Industrial Cleaning, Pharma & Healthcare, Food & Nutrition, Animal Nutrition, Agricultural & Environmental
Industrial Chemicals: CASE, Electronics, Essential Chemicals, Fine Chemicals, Advanced Materials & Additives, Chemicals, Lubricants & Metal Working Fluids, Other Applications, Textiles, Leather & Paper

At Azelis, our partnerships with customers and principals remain at the heart of our activities. As a leading global innovation service provider, our entrepreneurial approach to doing business is reflected in our can-do attitude.

Across our network of more than 70 application laboratories, our award-winning staff help develop formulations and provide technical guidance along the customers’ product development process. We combine a global market reach with a local footprint to offer a reliable, integrated and unique digital service to customers and attractive business opportunities to principals.

Striving to create a positive impact on the environment and communities around the world, we are top-industry-rated by Sustainalytics. Azelis is a leader in sustainability.

We aim to provide effective, sustainable, and reliable solutions. Our business is your business

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