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The QC Chemist / Analyst will be responsible for, but not limited to, the following duties:

Analytical Testing & Laboratory Operations

• Perform routine and non-routine quality control analysis of raw materials, packaging materials, in-process samples, and finished pharmaceutical products in accordance with approved specifications and pharmacopeial methods.
• Conduct HPLC analysis for assay determination, related substances testing, and impurity profiling of APIs and finished dosage forms.
• Perform UV-Visible spectrophotometric, FTIR, and Karl Fischer, melting point analyses as required.
• Carry out dissolution, comparative dissolution, and disintegration testing to support product equivalence and process optimization.
• Ensure accurate analytical weighing and proper use of analytical balances.

Method Validation & Stability Studies

• Execute analytical method validation and verification in compliance with ICH guidelines and GMP requirements (accuracy, precision, linearity, robustness, specificity).
• Support and manage stability studies including accelerated and long-term studies across relevant climatic zones.
• Monitor and trend stability data and ensure proper operation and monitoring of stability chambers.

Reagents, Standards & Utilities

• Prepare, standardize, label, and document volumetric solutions and reagents, including stability monitoring.
• Manage primary, secondary, and working reference standards, including qualification, requalification, and inventory control.
• Test pharmaceutical utilities such as purified water for conductivity, pH, and chemical compliance.

Equipment, Documentation & Compliance

• Perform routine calibration, verification, and qualification of laboratory instruments and equipment.
• Maintain accurate and complete documentation, including SOPs, test records, logbooks, deviation reports, and Certificates of Analysis (COAs).
• Act as custodian of retained and control samples.
• Participate in OOS/OOT investigations, deviation handling, and corrective actions (CAPA).
• Support internal audits, external audits, and regulatory inspections to ensure audit readiness

Training & Team Support

• Train, mentor, and supervise new laboratory recruits, interns, and trainees.
• Promote adherence to GMP, GLP, data integrity, and laboratory safety practices at all times