Position: Expert Quality Services (Product Complaints)
Job Description
The Global M&S Services is integral to Sanofi’s mission. Our team supports Global M&S teams in partnership with Business and Digital, driving priority and transformative initiatives. Team members of Global M&S Services Hubs act as partners in supporting 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 adherence to 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 complaint 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
- Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering, or Information Technology.
- Experience: 8 – 10 years of related experience in the pharmaceutical industry.
- Skills and Knowledge:
- Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools.
- Proficient in quality functions within the pharmaceutical industry.
- Experience working on manufacturing sites is an added advantage.
- Strong problem-solving skills, attention to detail, and organizational abilities.
- Ability to work in a team-oriented, flexible, and proactive manner.
- Analytical skills and the 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
- Application End Date: 30th June 2024