Job Description

Candidate should have expertise in handling and troubleshooting HPLC, GC-HS, FT-IR, UV, Dissolution Apparatus, and other laboratory instruments.

Strong knowledge of Quality Management System (QMS) documentation and analytical method validation is required.

Candidate will be responsible for managing QC activities, documentation, and compliance with regulatory standards.

Key Responsibilities

• Perform analysis and troubleshooting of HPLC, GC-HS, FT-IR, UV, Dissolution Apparatus, and other instruments.
• Ensure calibration and maintenance of laboratory instruments as per SOPs.
• Review analytical data ensuring compliance with GLP/GMP guidelines.
• Manage QMS documentation including Change Control, Deviation, Incident, and OOS/OOT investigations.
• Prepare and review SOPs, Specifications, STPs, and Analytical Test Reports.
• Handle CAPA and ensure timely implementation.
• Coordinate with QA, Production, and R&D for smooth QC workflow.
• Ensure data integrity, ALCOA+ compliance, and audit trail reviews.
• Participate in regulatory audits such as USFDA, MHRA, EU-GMP.
• Prepare and review Analytical Method Validation protocols and reports.

Required Skills

• Strong analytical and problem-solving skills for troubleshooting laboratory issues.
• Experience with software such as Empower, Chromeleon, OpenLab, LabSolutions, and MS Office.
• Expertise in Analytical Method Validation and data interpretation.
• Strong documentation skills for SOPs, STPs, and validation reports.
• Fluent English communication skills.
• Understanding of statistical analysis for method validation.
• Knowledge of data integrity and audit compliance.