Job title : Head- Quality Assurance
- Location - Mumbai
- 40% Remote working and 20 % of travel expected
- Job type: Permanent

Our Team:
External manufacturing India is managing Sanofi products manufactured at CMO s (Contract Manufacturing Organizations) located in India and other Asia pacific region. EM India is managing various types of formulations including solid orals, semi-solid, liquids and parentals. Our team is managing activities related to manufacturing, Quality, Regulatory and supplies of products manufacturing at CMO s.
Purpose: Ensuring implementation and monitoring of the Quality systems at Sanofi s External manufacturing sites as per cGMP and Sanofi Global quality document requirements in order to ensure the quality of products delivered to market.
Our Mission: We Lead and manage the Quality strategy within the External Manufacturing site s network to ensure that drug products manufacturing and distribution activities are in compliance with the Global Quality standards and applicable regulatory requirements.
Main responsibilities: Operational Management of CMOs:




- Lead and manage the Quality operations team, ensures the cGMP and Quality Management Compliance at CMOs.
- Management and ensuring Operational activities of pharmaceutical products at identified CMOs comply with the requirements of the Sanofi Quality directives and meet all relevant cGMP regulatory requirements.
- Monitor and ensuring that all the drug products are timely released in accordance with the registered specifications and in accordance with local regulations.
- To ensure validations, qualifications at CMO site.
- Ensuring the compliance of the product through testing as per specification, change management, stability studies, deviation and investigation, OOS and market complaint systems.
- Participate and guide QA managers team for appropriate evaluation and implementations of Quality compliance at CMO s.
- Ensuring the CMO compliance as per the respective Quality Agreements.

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📌 Head Quality Assurance Operations (Mumbai)
🏢 Sanofi
📍 Mumbai