M&S Services, Manager Quality Services, Product Complaints Budapest

at  Sanofi US

EXPERIENCE:

• 10 – 12 years of related experience in the pharmaceutical industry with 5+ years in Quality Assurance and/or Corporate Quality
• 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

• Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements
• Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments
• Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections
• 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. Also identify and implement continuous improvement opportunities. Aswell as, provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness
• Assess, evaluate, and follow up on product technical complaints, creating final reports and response letters for authorities. Generate evaluations for early risk detection and trend analysis, supporting the Drug Safety Officer. Participate in creating and presenting presentations, SOPs, and training materials
• Conducting thorough analyses to identify the root causes of defects reported in customer complaints, utilizing IT tools for data accuracy. Aswell as, comprehensive review of batch records, correlating relevant manufacturing data with quality events and deviations to elucidate reported defects. Proactively proposing areas for improvement and participating in the execution of identified corrective and preventive actions