Job Description:

Position: Sr. Officer/Executive - QC

Location: Bhimpore - Daman

Experience: 5 - 8 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 R&D; 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: Robust 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.
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📌 Sr Officer/executive Diu
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