The role will work closely with R&D;, QC, QA, Production, Regulatory Affairs, Engineering and other cross-functional teams to support analytical method lifecycle management and ensure inspection readiness.

Key Roles & Responsibilities

Analytical Method Validation (AMV)
Plan, coordinate, execute, and document analytical method validation activities.
Prepare, review, and execute Analytical Method Validation Protocols and Reports.
Perform analytical method validation in accordance with current applicable guidelines, including ICH Q2(R2) and relevant regulatory requirements.
Evaluate method suitability based on the intended purpose and analytical procedure.
Perform validation studies for:
Assay
Related substances / impurities
Dissolution
Content uniformity
Identification
Preservative content
Residual solvents
Water content
Elemental impurities, where applicable
Other physicochemical and chemical analytical methods
Evaluate validation parameters such as:
Specificity
Accuracy
Precision
Repeatability
Intermediate precision
Linearity




Range
LOD
LOQ
Robustness
Solution stability
Filter compatibility, where applicable
Establish scientifically justified acceptance criteria.
Review and interpret validation results against predefined acceptance criteria.
Identify atypical trends or failures during validation and initiate appropriate investigations.
Ensure validation activities are completed within approved timelines.

Analytical Method Development Support
Support development and optimization of analytical methods in collaboration with R&D; / Analytical Development.
Evaluate analytical procedures for specificity, sensitivity, precision, accuracy and robustness.
Support optimization of HPLC/UPLC/GC chromatographic conditions.
Evaluate column selection, mobile phase, flow rate, wavelength, temperature and other chromatographic parameters.
Support forced degradation studies and assessment of degradation product

📌 Qc Analytical Method Validation Baddi
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