We’re Hiring: QA Specialist (Market Complaint Management)
Are you a detail-oriented Quality professional with a knack for problem-solving? We are looking for a Market Complaint Handling expert to join our team and drive quality excellence!
Key Responsibilities:
· Logging and Registration: Promptly recording every complaint (verbal or written) in a centralized Market Complaint Register with a unique reference number.
· Initial Categorization: Triaging complaints into categories like Critical (life-threatening), Major (serious quality defect), or Minor (minor packaging or labeling issues) to prioritize action.
· Investigation Management: Coordinating cross-functional teams (Production, QC, R&D) to identify the root cause using using appropriate 6M tool.
· Sample Analysis: Coordinating with Quality Control (QC) to analyze complaint samples and reserve samples to confirm reported defects.
· CAPA Implementation: Initiating and monitoring Corrective and Preventive Actions (CAPA) to address the immediate issue and prevent its recurrence.
· Regulatory Reporting: Notifying regulatory authorities (e.g., filing a Field Alert Report (FAR)) for critical defects that could require a product recall.
· Customer Communication: Preparing formal response letters for customers or marketing departments detailing the investigation’s findings and actions taken.
· Trending and Review: Performing periodic trend analysis (quarterly or half-yearly) to identify recurring issues and provide insights for continuous improvement.
What We’re Looking For:
Experience: 6 to 10 years in QA/Compliance.
Skills: Proficiency in GMP (Good Manufacturing Practices), strong analytical and problem-solving abilities, excellent documentation skills, and knowledge of regulatory requirements (e.g., FDA 21 CFR Part 211, ICH Q10).
Location – Jadcherla, Unit 7 (OSD formulation)
Position – Executive / Sr. Executive
Interested candidates can send their CV to PavanKumar.Gurramkonda@Aurobindo.com
Hiring Alert!!
