Biotechnology Job at Sanofi | Quality Services Specialist | Apply Now
Sanofi, a global leader in healthcare and scientific innovation, is hiring a Specialist, Quality Services (Product Complaints) for its Hyderabad hub. This biotechnology job is a critical role within the Global M&S Services, acting as a vital link between R&D and manufacturing to ensure the safety and quality of innovative drugs and vaccines. A Sanofi career offers the opportunity to work in a dynamic, international environment that is pioneering the use of Artificial Intelligence (AI) to accelerate global health impact.
- Job Position: Specialist, Quality Services (Product Complaints)
- Location: Hyderabad, India
About the Company
Sanofi is a global life sciences company dedicated to transforming scientific innovation into solutions for rare diseases, oncology, immunology, and vaccines. Recognized as one of the best pharmaceutical companies globally, Sanofi emphasizes a supportive, future-focused corporate culture. The company is committed to equal opportunities and invests in its employees through a “Total Self” culture and gender-neutral parental leave.
Job Overview
The primary focus of this role is the end-to-end management of Product Technical Complaints (PTC) for medical devices, pharmaceuticals, biologics, and combination products.
Key Responsibilities:
- Complaint Investigation: Act as the Investigator Leader for medical device and combination product complaints, conducting investigations according to established procedures.
- Data Analysis: Perform comprehensive reviews of batch records and correlate manufacturing data with quality events to identify reported defects.
- Risk Assessment: Enter complaints into the global database, evaluate them for severity and risk, and ensure timely processing and closure.
- Stakeholder Collaboration: Coordinate with cross-functional teams including Manufacturing sites, Pharmacovigilance, Regulatory, and Medical Information for complaint management.
- Reporting & Compliance: Write detailed investigation summaries in English and prepare periodic reports for the Medical Device Quality Organization (MDQO).
- Audit Support: Provide essential support during internal audits and regulatory inspections, performing quality checks on all PTC activities.
- Process Improvement: Proactively identify areas for improvement within the Quality Management System (QMS) and ensure Hub-related GxP documentation is maintained.
Qualifications and Experience
To qualify for this life sciences job, candidates must possess the following technical background:
- Education: Graduate degree in Life Sciences, Engineering, or Biotechnology.
- Experience: 3 to 5 years of relevant experience in quality services or product complaint handling.
- Languages: Proficiency in English is preferred for writing investigation summaries and communicating globally.
- Technical Skills: Ability to handle complex GxP activities and ensure adherence to safety rules and Sanofi standards.
Pursuing a biotechnology job at Sanofi as a Quality Services Specialist is a high-impact move for professionals dedicated to product safety and regulatory excellence. This Sanofi career path provides the empowerment to implement innovative ideas while working on a diverse portfolio ranging from vaccines to rare disease treatments. If you are a graduate in Life Sciences or Engineering with at least three years of experience in product complaint investigations, this role in Hyderabad offers a transformative environment to grow your talent globally.
