Sr. Specialist - Quality Services (Product Complaints)
Location: Hyderabad, India
Job Type: Permanent, Full-time
Application Deadline: August 22, 2025
Estimated Salary: ₹9 – ₹13 LPA (based on experience and role expectations)
About the Role:
Sanofi is looking for a Sr. Specialist – Quality Services (Product Complaints) to take ownership of complaint lifecycle management for a wide array of healthcare products including medical devices, biologics, and pharmaceuticals. In this role, you will ensure adherence to global regulatory standards, provide leadership in complaint assessment and reporting, and help drive continuous improvement and audit readiness across Sanofi’s global product quality function.
Key Responsibilities:
Complaint Management:
Manage end-to-end product complaint handling and Field Alerts from receipt to closure, ensuring full compliance with Sanofi policies and global regulations.
Evaluate severity and risk of complaints, ensuring prioritization and timely processing.
Input complaints into the global database, track activities for assigned manufacturing sites, and generate monthly reports.
Ensure all complaint fields are accurately completed and assign cases to the correct investigation site.
Provide acknowledgement or resolution letters to complainants when applicable.
Investigation Coordination:
Facilitate complaint investigations in coordination with internal/external manufacturing, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and other stakeholders.
Identify if the complaint involves Adverse Events, PV Special Situations, or suspected counterfeit and ensure relevant departments are informed.
Support the Field Alert Reports (FAR) team and regulatory inspections with accurate documentation and timely updates.
Ensure closure of complaint records within defined timelines with final reviews and updates.
Quality Oversight & Continuous Improvement:
Perform quality checks on PQC (Product Quality Complaint) activities.
Maintain inspection readiness, lead or support internal audits, and participate in ad-hoc task forces.
Recommend and implement process improvements for complaint handling.
Lead and manage training programs for complaint-handling procedures.
About You:
Experience:
3–7 years of relevant pharmaceutical industry experience.
Strong knowledge of cGMPs, FDA regulations, ICH guidelines, and complaint database/reporting tools.
Previous exposure to manufacturing site environments is highly preferred.
Skills:
Excellent problem-solving, analytical, and organizational skills.
Ability to multi-task under pressure, work independently and collaboratively in a global team.
Strong communication skills with a proactive and flexible mindset.
Education:
Bachelor’s or Master’s in Life Sciences, Healthcare, Engineering, or Business Administration.
Languages:
Fluency in English, both written and verbal.
Why Join Sanofi?
Work in a future-focused, AI-driven, and inclusive global team.
Grow your career through global mobility, cross-functional projects, and learning programs.
Access a robust benefits package, including high-quality healthcare, wellness programs, and 14 weeks of gender-neutral parental leave.
Be part of an organization that believes in breaking boundaries, building smart solutions, and making a global impact on patient lives.
Join us in chasing the miracles of science. Let’s pursue progress and discover extraordinary – together.
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