R&d Quality Engineer

il y a 3 jours

Marseille, France Innate Pharma Temps plein

Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer._

**Overall Objectives & Purpose of the role**:
Within the Compliance & Operations division, and working with the Quality & GxP Compliance team (5 people) under the responsibility of the Manager, R&D Quality Assurance, you will contribute to the implementation of the Company's quality system and data integrity principles, and participate proactively in the continuous improvement process, in compliance with applicable regulatory requirements in a GxP context.
You will be able to produce reliable work on a diverse range of missions and projects, which you will be able to prioritize. You'll be working in a highly dynamic environment, where you'll have to adapt to often tight deadlines.

**Main responsibilities & key tasks**:
**Develop, maintain and improve Innate Pharma's Quality System in line with applicable regulatory requirements and the Company's strategy**:

- Ensure document management, i.e. organize, draft and review documents related to the Company's activities (procedures and instructions),
- check records relating to laboratory activities (protocols, study data, equipment documents, etc.),
- manage corrective, preventive and improvement action plans based on non-conformities, audits and assessment results,
- use, or create when necessary, data analysis tools to evaluate and improve the quality system.

Internal and external audits- conduct internal audits to assess and monitor the compliance of processes and studies with standards, procedures and protocols,

**Experience & Qualifications**:

- Bac+5 in a scientific field supplemented by training in Quality or equivalent professional experience,
- 3 to 5 years' similar experience in biology, biotechnology and/or the pharmaceutical industry,
- Good knowledge of the normative and regulatory environment applicable to laboratory activities and drug development, including GxP in general,
- Audit training and experience.

**Competencies, Skills & Behaviours**:
**Technical Competencies Additional Skills/ Behaviours**:

- ISO standards
- GLP
- GCLP
- ICH
- Audits
- Proficiency in office software and electronic document management tools
- Writing skills.
- Ability to use common sense to find effective solutions while maintaining an appropriate level of quality and compliance
- Pragmatism and rigor
- Team spirit and interpersonal skills
- Ability to interact at all levels of the organization, including peers at function level and other departments such as R&D, Regulatory Affairs, support functions, Program and Project Managers.
- Effective communication (oral and written)
- Motivation, commitment and autonomy
- Ability to work in a dynamic environment and meet tight deadlines
- Ability to be productive and handle significant workloads
- Flexibility in work planning to adapt to program priorities and Company activities
- Travel in Europe and abroad to be planned
- French and English read and spoken.
- NB: This job description is designed to describe a series of main tasks that may be encountered. It is not intended to be an exhaustive list of tasks and may be modified in consultation with the incumbent to reflect changes in the position or organization._
- Innate Pharma believes in equal opportunities and welcomes all qualified applicants for employment without discrimination._

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