Senior Qc Analyst

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.