Job Title: Specialist, Quality Services – Product Complaints
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Industry: Pharmaceuticals | Medical Devices | Life Sciences
Company: Sanofi
Sanofi is seeking a Specialist, Quality Services – Product Complaints to join its Global Manufacturing & Supply Services team in Hyderabad. This role plays a critical part in managing Product Technical Complaints (PTCs) across pharmaceutical products, biologics, medical devices, and combination products, ensuring compliance with global regulatory and quality standards.
The position offers exposure to cross-functional collaboration, global quality systems, and regulatory-driven investigations, supporting Sanofi’s mission to deliver safe, high-quality, and innovative healthcare solutions worldwide.
Manage and investigate Product Technical Complaints (PTCs) in compliance with global regulatory and quality requirements
Handle complaints related to pharmaceuticals, biologics, medical devices, and combination products
Act as Investigation Lead for medical device and combination product complaints, conducting investigations as per applicable SOPs
Perform in-depth review of batch records and manufacturing data, correlating quality events, deviations, and reported defects
Enter, assess, and track complaints in global complaint management systems, ensuring accurate severity and risk evaluation
Ensure timely processing, investigation, documentation, and closure of complaints within defined timelines
Collaborate with cross-functional stakeholders including Manufacturing, Customer Service, Medical Information, Pharmacovigilance, Regulatory Affairs, Quality, Legal, Commercial Operations, Sales, and Risk Management teams
Prepare clear and detailed investigation summaries and reports in English
Support internal audits, regulatory inspections, and quality reviews related to complaint handling
Perform quality checks on complaint management activities and ensure compliance with Sanofi Quality Management System (QMS) requirements
Identify continuous improvement opportunities and support implementation of process enhancements
Ensure all GxP documentation, training, and quality records are completed accurately and on time
Participate in product-specific complaint discussions and provide timely expert feedback
Prioritize and expedite investigations for high-risk and critical complaints
Education
Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Engineering, or a related scientific discipline
Experience
3 to 5 years of relevant experience in Quality Services, Product Complaints, Complaint Handling, or Quality Assurance within the pharmaceutical, biotechnology, or medical device industry
Skills & Competencies
Strong understanding of GxP, Quality Management Systems, and regulatory requirements for complaint handling
Experience with medical device and combination product complaint investigations preferred
Excellent analytical, documentation, and investigation skills
Strong stakeholder management and cross-functional collaboration abilities
High attention to detail and ability to manage multiple priorities under regulatory timelines
Proficiency in written and spoken English
Familiarity with global complaint databases and quality systems
Be part of a global, science-driven organization committed to improving patient outcomes
Work in an international and collaborative environment with diverse teams and stakeholders
Access structured career development, learning opportunities, and global mobility
Benefit from a competitive rewards and benefits package, including health and wellness programs
Contribute to innovative quality and compliance initiatives that support future product launches
Sanofi is an equal opportunity employer and is committed to fostering an inclusive and diverse workplace. All qualified applicants will be considered without regard to race, color, religion, gender, age, disability, sexual orientation, gender identity, or any other characteristic protected by law.
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