Manager Quality Control

Assistant Manager Quality Control

-------------------------------------------------------------------------------------------------

Sampling and testing of intermediates, stability and finished products received or manufactured at Sanofi India Limited at Goa site and compile the relevant documentation in order to ensure that the products meet the prescribed specification prior to release for sale and distribution.

Raw Materials:

• Planning of Sampling, Identification (Raman/FTNIR), Testing and Release of RM received at site.
• Involve in planning activity with Packing/Manufacturing/IPQA and Warehouse department and coordinate accordingly.
• Handling of Just in time (JIT) materials.
• Coordinate with External testing laboratory for on-time receipt of reports.
• Qualifying a New Vendor/Supplier for RM.
• Engage with procurement team to Exit from Monosource (MSEP) situation for RM
• Perform Third Party Audits (API/Excipents/PM)

Additional Responsibilities:

• Lead Quality Control testing activities and ensuring GLP compliance of laboratories.
• Establish quarter wise PROJECTS/GOALS/PRIORITIES.
• Qualification of Instrument/Equipment. (DQ, IQ, OQ and PQ)
• Preparation of Standard operating procedures (SOP’s) and ensuring the implementation without any deviation.
• Coordinate to ILI and full scale OOS/OOT investigation.
• Change control and Deviation Management.
• Quality Risk Assement (QRA)
• DIRA tool review and execution.
• Nitrosamine Impurities management(NDMA)
• ICH Q3D management.
• Maintenance of Reference Standards, Primary Standard and Working Standard.
• Validation of Analytical Method as per the current guidelines.
• Preparation of Specifications and Test procedure in accordance with currentmonograph or pharmacopeias. (Inhouse as per the validated document)
• Verifying the analytical method from current monograph.
• Test manager role for QC instruments.
• Support QA function in internal and vendor audits.
• To carry out the Method transfer for various products.
• LEAN Management.

Grade: L2-2

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.

Sanofi achieves its mission, in part, by offering rewarding career opportunities which inspire employee growth and development.  Our 6 Recruitment Principles clarify our commitment to you and your role in driving your career.