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.
Solid understanding of data integrity and audit trail compliance.

Required Qualification: - B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

Salary :- Upto 8.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-

📌 Sr Officer/executive Qc Diu
🏢 Quality HR India
📍 Diu