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Manager Quality Services (Product Complaints
5-12 years
Hyderabad / Secunderabad
1 vacancy
Manager Quality Services (Product Complaints
Sanofi
posted 16d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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.
- Manages and ensures the compliance of all Quality processes and documentation with applicable regulations and anticipates regulatory evolutions.
- 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.
- Comprehensive review of batch records, correlating relevant manufacturing data with quality events and deviations to elucidate reported defects.
- Physical examination of returned complaint samples (wherever applicable) to pinpoint the exact nature of defects causing customer dissatisfaction.
- Collaborating with production and laboratory departments to gather comprehensive field data for investigations.
- Entering all findings diligently into IT systems, ensuring the integrity and conformity of data related to customer complaints.
- Proactively proposing areas for improvement and participating in the execution of identified corrective and preventive actions.
- Writing detailed investigation summaries in English, as required.
- 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.
- 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.
- Bachelor s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology.
Employment Type: Full Time, Permanent
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