QC Executive
Quality HR Services · Not specified · onsite · Posted 28d ago
Undisclosed6–7 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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.
- 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.
B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry
Sourced from naukri
Skills
Data InterpretationInstrumentationlaboratory instrumentsAnalytical Method Validationcorrective and preventive actionauditsChemistryCAPAChange ControlMethod DevelopmentHPLCChromeleonmaintenancecompliance
About Quality HR Services
Quality HR Services
Recruitment
30
employees
2017
9 years old
Vapi, Gujarat
India
₹3.1L PA avg
Avg at Quality HR Services
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Quality HR Services
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