Sanofi want to build a healthier, more resilient world. We turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.
Post : Expert Quality Services (Product Complaints)
Job Description
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.
• 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.
• 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.
• 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.
• Identify and implement continuous improvement opportunities.
• 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.
Candidate Profile
• Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology.
• 8 – 10 years of related experience in the pharmaceutical industry.
• Knowledge of cGMP’s, 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.
• 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.
Additional Information
Experience : 8 – 10 years
Qualification : Bachelor’s or Masters in Life Sciences/Healthcare
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Product Complaints
End Date : 30th June 2024
See All Hyderabad Alerts B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
.png)
