- 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.
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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.
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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
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