Specialist Quality Services (Product Complaints)

• 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.