Global M&S Services, Specialist Quality Services - Product Complaints

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).

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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.

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