Cmc Project QA Manager Dry Forms H/F Excelya

About the Job

At Excelya, we embody Audacity, Care, and Energy. We are seeking a dedicated CMC Project Quality Insurance professional to join our team, where you will be instrumental in ensuring quality throughout the CMC (Chemistry, Manufacturing, and Controls) processes. This role provides an exceptional opportunity to work in a supportive environment that prioritizes collaboration and innovation.

In this position, you will work closely with cross-functional teams to uphold the highest quality standards for our CMC projects, facilitating compliance with regulatory requirements and contributing to the overall success of product development.

Main Responsibilities

- Quality monitoring of product development projects (in-house or outsourced) for CMC (Chemical Manufacturing and Control)
- As a member of the CMC project team in the role of QA-CMC, you will ensure the overall quality of pharmaceutical development activities from the active ingredient to the investigational medicinal product (end to end)
- Participating in the drafting and updating of quality agreements
- Evaluating and ensuring the compliance of deliverables and development support studies necessary for the preparation of drug specification files (PSF) with current quality standards (quality review of Product Specification Files, techniques, standards, protocols/stability reports/validation and analytical transfer, expiry dates, MBR, etc.) and deliverables supporting the drafting of marketing authorisation files
- Reviewing files for clinical batches of active ingredients and investigational injectable medicinal products with a view to their release
- Assessing deviations, change control, anomalies, OOX, CAPA, etc.
- Leading or contributing to the necessary risk analyses justifying the CMC development strategy
- Also participating in due diligence
- The products concerned may be injectables or dry forms.