Job title: Global M&S Services, Specialist Quality Services - Product Complaints

• Location: Budapest
  

About the job

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.
• Knowledge of cGMPs, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools.
• Should be knowledgeable in Quality functions of pharmaceutical industry.
• Experience of working on manufacturing sites is an added advantage.

Soft and technical 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).

Why choose us?

• Work from an "Office of the Year 2023" award winner with flexible home office policy.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks.
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.

#Sanofi #WeNeverSettle #SanofiCareers #PursueProgress #DiscoverExtraordinary #joinsanofi #careerswithpurpose #LI-EUR #LI-Hybrid

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, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!