PHARMAFull-time
Specialist Quality Services (Product Complaints)
By Admin · Quality Assurance & Quality Control
HYDERABAD (IN)ONSITEPOSTED: 8/19/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities & Product Complaint Management
Process and manage Product Technical Complaints (PTC) for pharmaceuticals, medical devices, biologics, and drug-device combination products in compliance with global quality and regulatory standards.
Perform intake, translation, triage, and database entry of technical complaints, assessing incoming reports for Adverse Events (AEs), Pharmacovigilance (PV) Special Situations, and Field Alert Reporting (FAR) triggers.
Categorize complaints based on risk severity, patient safety impact, and product quality defects, facilitating fast-track complaint processing for high-priority investigations and suspected counterfeits.
Coordinate complaint sample retrieval, physical inspection tracking, and image documentation in global Quality Management Systems (QMS).
Cross-Functional Investigation & Regulatory Compliance
Collaborate with manufacturing sites, Quality Control, Pharmacovigilance, Medical Information, Customer Service, and Regulatory Affairs to ensure timely root cause analysis and investigation closure.
Manage QMS documentation, GxP records, lot verification, and defective quantity reconciliations while strictly adhering to data privacy and data integrity protocols.
Draft, review, and issue formal complaint acknowledgement letters and investigation outcome responses to complainants and healthcare professionals.
Process contract manufacturing (toll-out) complaints in enterprise systems (such as QualiPSO) from intake through final closure.
Benefits & Total Rewards
Comprehensive health and wellbeing coverage, prevention programs, and at least 14 weeks of gender-neutral parental leave.
Career mobility opportunities across Sanofi's global Manufacturing & Supply (M&S) Services Hub network.
REQUIRED VERIFIED SKILLS
Product Technical Complaints (PTC)
Pharmacovigilance (PV) Intake
Quality Management Systems (QMS)
GxP Compliance
Adverse Event Triage
Root Cause Investigation
Sample Management
Field Alert Reporting (FAR)
Lot Number Verification
COMPENSATION & REWARDS
₹4.5L - 7.5L per annum
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global biopharmaceutical company dedicated to human health. It researches, develops, manufactures, and markets innovative therapeutic solutions with a focus on specialty care, vaccines, general medicines, and consumer healthcare products. The company aims to prevent and treat a wide range of diseases worldwide.
TEAM SIZE: Approximately 90,000 employees
INDUSTRY: Pharmaceuticals / Biotechnology
RECOMMENDED TRAINING
1/5
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