Senior Specialist Quality Services (Product Complaints)

Job description

Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.

• Collaborate with internal / external stakeholders viz Cross functional teams, Manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments for complaint management.
• Ensure to complete all training in a timely manner.
• Enter complaints into the global database and evaluate complaints for severity and risk, ensure timely processing and closure of the complaints.
• Participate in ad-hoc meetings for product-specific complaint issues and provide timely feedback on complaint investigations.
• Manages and ensures the compliance of all Quality processes and documentation with applicable regulations / Sanofi standards. Handle QMS records any discrepancies and ensure completion within defined timelines.
• Proactively identify areas for improvement and support the implementation.
• Ensure the documentation of Hub related GxP activities.
• Abide any other responsibilities as assigned / aligned by manager.
• Prepare and update data (timeline quality KPIs) periodically for team meetings.

To support team initiative / continuous improvement projects.

Receipt of inquiry / complaint classify / categorize the complaint based on its potential impact on product quality or patient safety as per defined timelines.

Act as a regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management.

Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable).

Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site.

Ensure completion of the investigation. Perform final review / update the complaint record and close as per defined timelines.

Ensure acknowledgement of Complaint and / or response letter to Complainant (As applicable).

Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement.

Maintain compliance with all relevant regulatory requirements for complaint management and reporting.

Consulting to FAR team in case of any filed alert expected (as applicable).

Requirements / Qualifications :

Minimum 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.

Bachelor s or Masters in Life Sciences / Healthcare, Business Administration, Engineering or Information Technology.

Proficient in problem-solving, attention to detail, and organizational skills.

Work in a team-oriented, flexible, and proactive manner.

Analytical skills and ability to multitask in a stressful environment.

Skills Required

Complaint Management, Gmp, Pharmacovigilance