Specialist Quality Services - Hyderabad
10 hours ago
Job description
- Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.
- Evaluate complaints for severity and risk, ensuring timely review and processing.
- Prioritize and enter complaints into the global database, monitoring complaint activity for assigned regions/countries/manufacturing sites.
- 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.
- Collaborating with production and laboratory departments to gather comprehensive field data for investigations.
- Focus on operational tasks within the compliant handling process.
- Ensure qualitative, GMP-compliant processing of the complaint process.
- Focus on independent, function-specific duties and responsibilities.
Experience:
- 1-3 years of related experience in the pharmaceutical industry.
- Should be knowledgeable in Quality functions of pharmaceutical industry.
Required skills:
- 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.
Education:
- Bachelor s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology.
Languages: Excellent knowledge of English language (spoken and written)
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