Operational Quality Assurance Pharmacist

il y a 1 mois

Dreux, France Ipsen PharmSciences SAS Temps plein

**Ipsen** is a rapidly expanding biopharmaceutical group specializing in the development of innovative medicines in oncology, neuroscience, and rare diseases. Our mission is to enhance patients’ quality of life by discovering new solutions for targeted, debilitating diseases.

**Why Ipsen?**
- ** Patient-Focused**: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
- ** Employee Care**: We care for our employees, who are the ambassadors making a real difference.
- ** Bold Leadershi**p: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
- ** Growth Opportunities**: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

In a International environment, as part of the **Global Quality Organization **dedicated to** Pharmaceutical Development** (across three European sites), the **Operational Quality Assurance Pharmacist** will play a crucial role in providing access to innovative medicines for patients worldwide.

**Key Responsibilities**:

- Release batches of semi finished and finished products (Investigational Medicinal Products) for clinical trials.
- Serve as the CMC project quality representative, defining quality requirements for products at various stages of pharmaceutical development.
- Contribute to the implementation and adherence to procedures and instructions at Ipsen Pharmaceutical development sites and Ipsen’s CDMOs.
- Ensure the execution of Quality Technical Agreements with CDMOs and represent the Quality Assurance Pharmaceutical Development, Dreux department at meetings.
- Foster a continuous improvement mindset within the Quality Assurance department.
- Promote Quality through training, awareness, and communication initiatives.

**Qualifications**:
Pharmacist - Pharmaceutical industry - registrable with the pharmacists' order (CNOP)

Minimum 5 years’ experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, or Manufacturing Operations

First QP experience (batch certification ) of at least 3 years

Knowledge of injectable and oral forms

Solid working knowledge of regulatory requirements (FDA, ICH, EMA) including GxP principles

Demonstrated experience with third party manufacturing contractors

Experience in pharmaceutical development and clinical trials would be a plus as well as knowledge of regulatory dossiers and regulatory variations.

**Languages**:
French: native or bilingual

English: fluent or advanced

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