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Specialist Quality Services (Product Complaints)

2-6 years
Not Disclosed
10 July 29, 2025
Job Description
Job Type: Full Time Education: B.Tech/BBA/MBA/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.