R&D Quality Engineer (m/f/d)

TN France; France; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An innovative firm is seeking a dedicated R&D Quality Engineer to enhance its quality systems and ensure compliance with regulatory standards. In this role, you will manage documentation, conduct internal audits, and implement corrective actions to improve processes. Your expertise in the pharmaceutical industry and knowledge of ISO standards will be crucial in maintaining high-quality standards. Join a dynamic environment where your contributions will help shape the future of drug development and quality assurance across Europe.

Qualifications

• 3-5 years' experience in the pharmaceutical industry.
• Good knowledge of regulatory environments and GxP.

Responsabilités

• Ensure document management and review related to company activities.
• Conduct internal audits to monitor compliance with standards.

Connaissances

Document Management

Data Analysis Tools

Auditing

ISO Standards

GxP Knowledge

Formation

Bac+5 in a Scientific Field

Description du poste

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R&D QUALITY ENGINEER M/F/D

Your Responsibilities:

1. Ensure document management, i.e., organize, draft, and review documents related to the company's activities (procedures and instructions).
2. Check records relating to laboratory activities (protocols, study data, equipment documents, etc.).
3. Manage corrective, preventive, and improvement action plans based on non-conformities, audits, and assessment results.
4. Use or create data analysis tools to evaluate and improve the quality system.
5. Conduct internal audits to assess and monitor the compliance of processes and studies with standards, procedures, and protocols.
6. Conduct audits of service providers involved in the development of drug candidates.

Experience & Qualifications:

• Bac+5 in a scientific field supplemented by training in Quality or equivalent professional experience.
• 3 to 5 years' experience in biology, biotechnology, or the pharmaceutical industry.
• Good knowledge of the normative and regulatory environment applicable to laboratory activities and drug development, including GxP.
• Audit training and experience.
• Technical competencies: ISO standards, GLP, GCLP, ICH, audits.
• Ability to work in a dynamic environment and meet tight deadlines.
• Flexibility in work planning to adapt to program priorities and company activities.
• Willingness to travel within Europe and abroad.
• Fluent in French and English, both reading and speaking.