Shubhadeep Saha
Specialist Quality Services || M&S || Post Market Surveillance || Product complaints || Sanofi India|| exSenior Associate (Project Management) at Wipro|| Materiovigilance ||Medical Devices || Complaint Handling ||
- Role
- Specialist Quality Services at Sanofi
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Shubhadeep Saha
I believe that quality is more than just a checklist—it’s the foundation of trust between…
Experience
Specialist Quality Services
Aug 2024 — Present · Hyderabad, IN
Manage Product Technical Complaints(PTC) for medical devices, pharmaceuticals, biologics, and combination products, ensuring compliance with regulatory standards.• Collaborate with internal and external stakeholders, including cross-functional teams, manufacturing sites, and regulatory departments, for effective complaint management.Enter and evaluate complaints in the globaldatabase, ensuring timely processing, risk assessment, and closure.• Lead investigations for medical device and combination product complaints, performing root cause analyses as per established procedures.Review batch records and correlate manufacturing data with quality events to address reported defects.• Ensure compliance with investigation deadlines, reclassify PTC cases as needed, and consult stakeholders for additional information.Prepare detailed investigation summaries and periodic reports, supporting audits and regulatory inspections.Manage quality processes, documentation, and QMS records while ensuring adherence to Sanofi and regulatory standards.• Identify areas for process improvement and support the implementation of corrective actions.• Complete required training, ensure GxP activity documentation, and handle additional responsibilities as assigned by management.
Education
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor of Pharmacy - BPharm (hons.), Pharmacy
Sagar Institute of Research and Technology
B. Pharm (Hons.)
Dr. A. P. J. Abdul Kalam University Indore
Bachelor of Pharmacy, Pharmaceutics and Drug Design
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