Job Role- Senior Specialist Quality services - Product Complaints
Location-Hyderabad
About the job
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients' daily life, wherever they live and enabling them to enjoy a healthier life.
As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.
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The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.
Main responsibilities
- Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.
- Evaluate complaints for severity and risk, ensuring timely review and processing.
- Prioritize and enter complaints into the global database, monitoring complaint activity for assigned regions/countries/manufacturing sites.
- Conducting thorough analyses to identify the root causes of defects reported in customer complaints, utilizing IT tools for data accuracy.
- Comprehensive review of batch records, correlating relevant manufacturing data with quality events and deviations to elucidate reported defects.
- Collaborating with production and laboratory departments to gather comprehensive field data for investigations.
- Focus on operational tasks within the compliant handling process.
- Ensure qualitative, GMP-compliant processing of the complaint process.
- Focus on independent, function-specific duties and responsibilities.
About you
Experience:
- 1-3 years of related experience in the pharmaceutical industry.
- Should be knowledgeable in Quality functions of pharmaceutical industry.
Required skills:
- Proficient in problem-solving, attention to detail, and good organizational skills.
- Work in a team-oriented, flexible, and proactive manner.
- Analytical skills and ability to multitask in a stressful environment.
Education:
- Bachelor's or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology.
Languages: Excellent knowledge of English language (spoken and written)
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!