ESO Quality Specialist

hace 5 meses

Barcelona, España Galderma A tiempo completo

Description

This position needs to ensure Galderma products meet the Company quality standards and comply with the relevant government regulations according to the product applicable classification: cGMP, GDP, ISO, ICH or any relevant regulations and guidance. As ESO Quality Specialist, this person will rely on regulatory, industry and technical expertise to select, monitor, guide and promote Quality at CMOs/CDMOs and support Galderma Markets/distributors on products provided by CMOs. This person will also have an important role on the API suppliers.

Key Responsibilities

Promote improvement programs and alignments in all related CMO/CDMO.

Be actively involved in the resolution of critical/major quality issues (leading to supply issues) and to discrepancies found through audits, inspections, or complaints and their related investigations.

This position will accompany CMO/CDMO to favor continuous improvement program and preventive actions over corrective actions.

Provide expert interpretation and application of regulatory guidelines to ensure that CMO/CDMO/API Suppliers adhere to regulatory requirements and are consistent with industry standards.

Notify management of significant quality or regulatory issues that may impact product quality or regulatory compliance.

Skills & Qualifications

Solid experience in Quality Assurance role;

Strong knowledge of the applicable regulations for drugs, cosmetics, medical devices or a similar industry.

Capacity to negotiate and manage external partners.

Possess ability to work in matrix organization (affiliates, global, CMO/CDMO).

Communicate clearly and professionally in both writing and verbally in English and French.

Flexibility and agility in problem solving, providing direction to meet business objectives are expected

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

You will receive a competitive compensation package with bonus structure and extended benefit package

You will be able to work in a hybrid work culture

You will participate in feedback Loops, during which a personalized career path will be established

You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability

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