QA External manufacturing Specialist

Job description

Job Purpose:                        

Management of external manufacturing activities.

Job Responsibilities for external manufacturing activities:

1. Preparation of Quality Agreements with manufacturing subcontractors performing activities on behalf of SANOFI and follow up of its approval.

2. Following up CAPA implementation of Subcontractors’ audits.

3. Participating in projects to oversight products development activities at subcontractors.

4. Follow up Process validation Activities of Externally Manufactured products.

5. Oversight the Quality Activities at Subcontractors level, including following up Product Quality Review for Externally Manufactured Products / Deviations / Product Technical Complaints / change controls.

6. Perform Quality Expert Meetings with subcontractors to follow up the process and to ensure the compliance to cGMP, SANOFI requirements when applicable and with local regulations.

7. Perform final release of Externally Manufactured products at CMO level.

8. Participate in External Manufacturing Quality Review to review Quality KPIs with different subcontractors.

Key “MUST HAVE” competencies, skills & experiences

QA Experience from 2 to 5 years ( in Sanofi or other companies )

Bachelor of Pharmaceutical Sciences.

successful performance records

Good communication & Presentation skills.

Problem solving skills.

Report writing skills.

Ability to co-ordinate several inter-departmental activities.

Good command of MS Word, Excel & Power Point.

“Desirable” / compromise experience

Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.