Quality Assurance CMC

Orléans - France

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Mission scope:

Quality follow-up for pharmaceutical development projects (API to investigational drug product).
Active participation in CMC project teams as QA-CMC.
Drafting and updating quality agreements.
Reviewing and ensuring compliance of CMC deliverables and Product Specification Files.
Reviewing clinical batch documentation for injectable and solid dosage forms.
Evaluating deviations CAPAs OOX change controls.
Risk analysis and due diligence participation.

Ideal profile:

Pharmacist or Engineer with 3–5 years experience in Quality for sterile or solid dosage products.
Strong knowledge of GMP (Annex 1 & 13) and ICH guidelines.
Fluent in English autonomous pragmatic and solution oriented.

Mission scope:Quality follow-up for pharmaceutical development projects (API to investigational drug product).Active participation in CMC project teams as QA-CMC.Drafting and updating quality agreements.Reviewing and ensuring compliance of CMC deliverables and Product Specification Files.Reviewing c...