Expert Quality Services (Product Complaints)
Location: Hyderabad, India
Job Type: Permanent, Full-time
Application Deadline: July 31, 2025
Estimated Salary: ₹12 – ₹17 LPA (based on experience and market standards)
About the Role:
Sanofi is seeking an Expert – Quality Services (Product Complaints) to lead end-to-end complaint handling operations for a wide range of medical products, including pharmaceuticals, biologics, medical devices, and combination products. This role is essential for ensuring compliance with global regulatory requirements, maintaining inspection readiness, and driving operational excellence in product quality complaint (PQC) handling.
Key Responsibilities:
Complaint Lifecycle Management:
Handle Product Technical Complaints (PTC) and Field Alerts across product types, from receipt to closure.
Ensure full compliance with internal SOPs, regulatory requirements, and global standards.
Evaluate and prioritize complaints based on severity, risk, and potential regulatory impact.
Enter, track, and monitor complaints in the global quality database.
Maintain comprehensive complaint documentation and generate monthly complaint reports for assigned manufacturing sites.
Stakeholder Collaboration:
Work cross-functionally with departments including Manufacturing, Regulatory Affairs, Medical Information, Pharmacovigilance, Customer Service, Legal, and Risk Management.
Actively contribute to audits, regulatory inspections, and product-specific investigations.
Participate in ad-hoc issue-resolution teams and provide feedback on investigation outcomes.
Compliance & Continuous Improvement:
Perform quality checks on complaint records and prepare inspection-ready documentation.
Lead or contribute to continuous improvement initiatives related to PQC handling.
Provide regulatory interpretation and support training of quality complaint handling processes.
Support internal knowledge transfer by managing departmental training efforts.
About You:
Experience:
6–10 years of relevant experience in the pharmaceutical industry, particularly in quality assurance and complaint handling.
In-depth knowledge of cGMPs, FDA/ICH regulations, and complaint management tools and databases.
Prior experience working at manufacturing sites is a strong advantage.
Skills & Traits:
Strong problem-solving, analytical, and organizational abilities.
High attention to detail and ability to work under time-sensitive and high-pressure scenarios.
Team-oriented with strong interpersonal and communication skills.
Demonstrates a proactive, flexible, and quality-first mindset.
Education:
Bachelor’s or Master’s degree in Life Sciences, Healthcare, Engineering, Information Technology, or Business Administration.
Languages:
Fluent in English (verbal and written)
Why Sanofi?
Be part of a global life sciences leader that’s driving innovation with the power of AI and advanced data standards.
Work in an international environment, with global teams and cross-functional collaborations.
Enjoy a rewards package that reflects your impact, along with healthcare, wellness, and 14 weeks of gender-neutral parental leave.
Experience career growth through mobility, upskilling, and transformative projects.
Join Sanofi and help us chase the miracles of science. Let’s pursue progress and discover extraordinary – together.
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