Specialist Quality Services (Product Complaints)
Location: Hyderabad, India
Job Type: Permanent, Full-time
Application Deadline: August 27, 2025
Estimated Salary: ₹7 – ₹11 LPA (based on experience and industry standards)
About the Role:
Sanofi is hiring a Specialist – Quality Services (Product Complaints) to manage and process product technical complaints (PTCs) across a global portfolio, ensuring timely, compliant resolution while maintaining quality and regulatory standards. You will play a vital role in safeguarding product integrity and customer trust by coordinating complaint handling and supporting investigations with internal stakeholders.
Key Responsibilities:
Complaint Management & Documentation:
Receive, classify, and validate product complaints as PTC or non-PTC.
Categorize PTCs based on potential quality or patient safety impact in line with defined timelines.
Record complaint details in the global system, including lot number and quantity.
Process Fast Track complaints as per criteria and handle sample/picture uploads in the system.
Act as a regional hub for assigned countries, coordinating sample collection and data follow-up.
Investigation & Closure:
Communicate with complainants to collect missing information and ensure full documentation.
Identify if the PTC is associated with Adverse Events, Pharmacovigilance, or Special Situations and alert relevant teams.
Assign complaints to investigation-owning sites and ensure timely closure per SOPs.
Conduct final review and ensure complaint data fields are complete and compliant.
Send acknowledgment and/or response letters to complainants where required.
Escalate priority complaints, counterfeits, or health authority alerts as per urgency and regulatory norms.
Regulatory Compliance:
Ensure compliance with global and local complaint management standards, cGMPs, and internal SOPs.
Support Field Alert Reports (FAR) and provide consultation as applicable.
About You:
Experience:
2–6 years in pharmaceutical quality, with hands-on complaint handling experience.
Familiarity with cGMPs, complaint reporting tools, and regulatory frameworks (e.g., CFRs).
Experience on manufacturing sites is a plus.
Skills:
Strong analytical thinking and problem-solving mindset.
Excellent attention to detail, multi-tasking, and organizational skills.
Flexible and team-oriented, with a proactive and collaborative work approach.
Education:
Bachelor’s or Master’s degree in Life Sciences, Healthcare, Engineering, or Business Administration.
Languages:
Fluency in spoken and written English is required.
Why Join Sanofi?
Work on global health challenges with a diverse, future-focused team.
Take advantage of career mobility, learning opportunities, and international exposure.
Enjoy comprehensive benefits, including wellness programs, top-tier healthcare, and 14 weeks’ gender-neutral parental leave.
Be part of a high-performing environment where your ideas drive real-world impact.
If you're ready to play a key role in quality assurance and product integrity at one of the world’s most respected life sciences companies—this is your chance.
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