QC Executive

Job Summary

Position: QC Executive

Location: Bhimpore - Daman

Experience: 6-7 Years

Industries: Medical - Device

Responsibilities

• Analytical Instrumentation Testing
• Perform analysis and troubleshooting of HPLC, GC-HS, FT-IR, UV, Dissolution Apparatus, and other laboratory instruments.
• Ensure the proper calibration and maintenance of laboratory instruments as per SOPs.
• Review and interpret analytical data, ensuring compliance with GLP/GMP guidelines.
• Quality Management System (QMS) Documentation
• Manage QMS documentation, including Change Control, Deviation, Incident, OOS/OOT investigations.
• Prepare, review, and update SOPs, Specifications (Spec), Standard Test Procedures (STPs), and Analytical Test Reports.
• Handle CAPA (Corrective and Preventive Action) and ensure timely implementation.
• Manage day-to-day QC activities, including sample analysis, documentation, and reporting.
• Ensure smooth workflow within the QC department and coordinate with QA, Production, and RD teams.
• Ensure data integrity, ALCOA+ compliance, and audit trail reviews.
• Prepare for and participate in regulatory audits (USFDA, MHRA, EU-GMP, ANVISA, etc.).
• Analytical Method Validation (AMV) Method Development (use this as keyword)
• Prepare and review Analytical Method Validation (AMV) protocols and reports.
• Perform method validation activities, ensuring compliance with regulatory guidelines.

Required Skills

• Problem-Solving: Strong analytical skills to troubleshoot laboratory issues and deviations.
• Computer Proficiency: Experience with Empower, Chromeleon, OpenLab, or LabSolutions software, and MS Office.
• Method Validation Expertise: Experience in Analytical Method Validation (AMV) and data interpretation.
• Documentation Skills: Ability to prepare and review SOPs, STPs, Specifications, Analytical Test Reports, and Validation Reports.
• English fluency
• Knowledge of statistical analysis for method validation and trending.
• Strong understanding of data integrity and audit trail compliance.

Required Qualification

B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry