Expert Quality Services (Product Complaints)
Location: Hyderabad, India
Job Type: Permanent, Full-time
Application Deadline: August 30, 2025
Estimated Salary: ₹12 – ₹18 LPA (based on experience and market standards in pharma quality roles)
About the Role:
Sanofi is hiring an Expert in Quality Services (Product Complaints) to manage and lead product technical complaints and field alerts across pharmaceutical products, medical devices, biologics, and combination products. This role ensures regulatory compliance, drives continuous improvement, and supports cross-functional collaboration to ensure product quality and patient safety.
Key Responsibilities:
Complaint Handling & Compliance:
Manage end-to-end Product Technical Complaints (PTCs) and Field Alerts from intake to closure.
Ensure compliance with internal SOPs, regulatory requirements, cGMPs, and global quality standards.
Triage, prioritize, and enter complaints into the global quality system, maintaining database integrity and timely follow-up.
Evaluate severity and risk associated with complaints, ensuring prompt action for high-priority cases.
Cross-functional Collaboration:
Liaise with stakeholders across Manufacturing, Customer Service, Medical Information, Pharmacovigilance, Regulatory Affairs, Sales, Legal, and Risk Management teams.
Provide feedback and insight during product-specific complaint investigations and assist in root cause analysis.
Prepare and share monthly complaint reports with manufacturing sites and support audits and regulatory inspections.
Continuous Improvement & Training:
Participate in ad-hoc teams to address product-specific issues.
Identify opportunities to improve complaint handling workflows, system efficiencies, and documentation standards.
Provide regulatory interpretation, guide teams on best practices, and maintain inspection readiness.
Oversee training programs within the department and conduct quality checks on Product Quality Complaint (PQC) activities.
About You:
Experience:
6–10 years in the pharmaceutical industry, with deep understanding of cGMP, FDA regulations, and quality systems.
Prior experience in manufacturing or regulatory environments preferred.
Familiarity with complaint handling systems and reporting tools.
Skills:
Strong analytical, problem-solving, and organizational capabilities.
Ability to multitask in a dynamic, high-pressure environment.
Flexible and collaborative with a team-first mindset.
Education:
Bachelor’s or Master’s degree in Life Sciences, Healthcare, Engineering, Business Administration, or Information Technology.
Languages:
Fluent in English (spoken and written).
Why Join Sanofi?
Be part of a global mission to improve access to healthcare and elevate quality standards.
Experience a supportive, future-focused culture with clear career growth and mobility.
Access world-class benefits, including 14 weeks of gender-neutral parental leave, high-quality healthcare, wellness programs, and structured development pathways.
Collaborate with international teams and bring your voice to projects that impact patient outcomes worldwide.
Ready to safeguard global product quality and play a key role in healthcare innovation? Apply now and bring your expertise to Sanofi’s commitment to excellence.
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