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Specialist, Quality Services – Product Complaints

HYDERABAD (IN)ONSITEPOSTED: 9/29/2026
PHARMAFull time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
Sanofi

ROLE OVERVIEW

Sanofi's Global Manufacturing & Supply Services hub in Hyderabad is the operational backbone of the company's worldwide product quality agenda, and this Specialist Quality Services (Product Complaints) position sits at the frontline of post-market surveillance. The role owns intake, triage, categorization and closure of Product Technical Complaints across medical devices, pharmaceuticals, biologics and combination products — a workflow that directly protects patient safety and feeds the investigation, field alert and pharmacovigilance machinery of a 110,000-person life-sciences leader. Because Sanofi is investing heavily in AI-driven data standards and reusable quality data, specialists here gain exposure to modern QMS tooling and global cross-functional stakeholders. For an early-career quality professional, it is an exceptional launchpad: high regulatory visibility, structured GxP discipline and a clear route into broader quality, compliance and pharmacovigilance careers.

ROLE DEFINITION & RESPONSIBILITIES

  • •Intake, translate and record Product Technical Complaints into global quality systems, verifying lot numbers, defective quantities and complainant details.
  • •Triage each complaint to determine whether it involves an Adverse Event, Pharmacovigilance special situation, customer service matter or Field Alert Reporting.
  • •Categorize complaints by potential impact on product quality or patient safety, and fast-track priority, health-authority and suspected counterfeit cases.
  • •Liaise with manufacturing sites, Medical Information, Pharmacovigilance, Regulatory and Legal teams to drive complaint investigations to closure.
  • •Manage complaint samples end-to-end — requesting collection, updating photographs and sample information in the global system.
  • •Assign complaints to the owning investigation site, monitor progress and perform final review, update and documented closure within defined timelines.
  • •Issue acknowledgements and response letters to complainants, following up for additional information where required.
  • •Maintain Hub GxP documentation, QMS records and data-privacy compliance, proactively flagging opportunities for process improvement.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Healthcare, Engineering or Information Technology.
  • 1–3 years of related experience in the pharmaceutical, medical device, biologics or combination-product industry, ideally within a quality or complaint-handling team.
  • Working knowledge of pharmaceutical Quality functions and post-market complaint management processes.
  • Familiarity with QMS platforms, complaint databases and GxP documentation practices.
  • Excellent written and spoken English, including ability to translate non-English complaint narratives.
  • Strong attention to detail, analytical problem-solving and comfort multitasking in deadline-driven environments.
  • Team-oriented, flexible and proactive mindset with a compliance-first approach.

PREFERRED QUALIFICATIONS

  • •Hands-on use of QualiPSO or comparable complaint management software
  • •Exposure to medical devices and drug-device combination products
  • •Adverse Event identification and PV case intake experience
  • •Lean / Six Sigma continuous improvement certification
  • •Knowledge of 21 CFR Part 803 (MDR) and EU MIR reporting obligations

REQUIRED VERIFIED SKILLS

Product Technical Complaint (PTC) Handling
Quality Management Systems (QMS)
GMP / GxP Compliance
Pharmacovigilance Intake & Triage
Field Alert Reporting (FAR)
Complaint Categorization & Impact Assessment
Complaint Sample Management
Regulatory Reporting Timelines (FDA / EMA / CDSCO)
Quality Documentation & Data Privacy
Cross-functional Stakeholder Management

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

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

EXPECTED CAREER ROADMAP

From this role, a strong performer typically advances into Senior Specialist or Team Lead positions within Sanofi's Global M&S Services hub within two to three years, taking on mentoring, audit-facing responsibilities and process ownership. Lateral moves are equally realistic — into Pharmacovigilance & Drug Safety, Quality Assurance, Regulatory Affairs or Supply Chain Quality, particularly for candidates who build depth in device and combination-product complaints. Sanofi's global footprint opens international mobility, with manufacturing and quality hubs across Europe and the United States. Externally, the complaint-handling and QMS experience transfers directly to quality roles at other multinational pharma, medical-device and CRO organisations across Hyderabad, Bengaluru, Mumbai and Chennai.

APPLICATION ADVISORY

Lead your resume with complaint-handling metrics: number of cases processed monthly, average closure time and any audit or inspection findings you helped resolve. Quantify accuracy and right-first-time rates wherever possible. In interviews, be ready to walk through your triage logic — how you separate an Adverse Event from a routine technical complaint, when you escalate a Field Alert, and how you handle a suspected counterfeit. Brush up on 21 CFR Part 803, EU MIR timelines and CDSCO reporting basics, and rehearse one end-to-end complaint closure from intake to response letter.
RECOMMENDED TRAINING
1/5
The Fundamentals of Regulatory Affairs

The Fundamentals of Regulatory Affairs

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