SHEQ Manager & Qualified Person

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

#J-18808-Ljbffr