Senior Specialist Quality Services (Product Complaints)

Job Title: Senior Specialist Quality Services (Product Complaints)

Location: Hyderabad

Job Type: Permanent/Fulltime

About The Job

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

About you

• 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.
  
  

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