M&S Services, Senior Specialist Quality services, Product Complaints Budapest

at  Sanofi US

EXPERIENCE:

• 3 – 7 years of related experience in the 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

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

• Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements
• Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites
• Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations
• Focus on operational tasks within the compliant handling process. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections
• Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments
• Identify and implement continuous improvement opportunities in complaint management. Provide regulatory interpretation and guidance to internal teams and corporate partners
• Manage and oversee the training within the team. Perform quality checks on activities, prepare reports, and maintain inspection readiness