Sr. Officer/Executive - QC

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: 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

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 :-