Senior Qc Analyst

Proventech; Jigani; Presencial; INR 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

Proventech in Jigani, Karnataka is seeking a Senior Analyst - API & Stability Analysis to lead API/stability testing and data review. You will perform and review analyses using HPLC/UPLC/GC, support OOS/OOT investigations, and help ensure GMP data integrity and timely batch disposition.

You will mentor junior analysts, transfer methods, and coordinate with QA to close deviations and CAPAs, while maintaining compliance with regulatory inspections.

Formación

• 5 to 10 years of experience in pharmaceutical QC laboratories.
• Strong hands-on experience in API, Stability, Raw Material, and Finished Product analysis.
• Experience in GMP-regulated environments and regulatory inspections.

Responsabilidades

• Perform and review API and stability analyses.
• Execute and review chromatographic testing using HPLC and GC.
• Support closure of OOS, OOT, Deviations, and CAPAs.
• Conduct root cause investigations and implement corrective actions.
• Review analytical data for compliance with GMP and Data Integrity requirements.
• Support timely batch disposition and release activities.
• Mentor junior analysts and ensure adherence to laboratory procedures.

Conocimientos

Analytical chemistry

HPLC/UPLC/GC

Data interpretation

Method validation

GMP compliance

Root cause analysis

Mentoring

Analytical data review

Educación

M.Sc./B.Sc. in Chemistry

Herramientas

LIMS/CDS

Descripción del empleo

Note: Notice Period (Immediate -15 Days)

Position: Senior Analyst - API & Stability Analysis

Qualification:

• M.Sc./B.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or related discipline.

Experience:

• 5 to 10 years of experience in pharmaceutical QC laboratories.
• Strong hands-on experience in API, Stability, Raw Material, and Finished Product analysis.
• Experience in GMP-regulated environments and regulatory inspections.

Technical Expertise:

• HPLC, UPLC, GC, PSD, UV-Vis, FTIR, KF Titration.
• Analytical method validation, verification, and transfer.
• Chromatographic troubleshooting and data interpretation.
• Stability study management and trending.
• Empower/LIMS/CDS software proficiency.
• Analytical data review and laboratory investigations.

Key Responsibilities:

• Perform and review API and stability analyses.
• Execute and review chromatographic testing using HPLC and GC.
• Support closure of OOS, OOT, Deviations, and CAPAs.
• Conduct root cause investigations and implement corrective actions.
• Review analytical data for compliance with GMP and Data Integrity requirements.
• Support timely batch disposition and release activities.
• Mentor junior analysts and ensure adherence to laboratory procedures.

Expected Benefits:

• Clearance of analytical testing backlog.
• Improved turnaround time (TAT) for testing and investigations.
• Timely closure of OOS, OOT, and Deviation reports.
• Enhanced quality of investigations and data review.
• Improved support for batch release activities while maintaining GMP compliance.