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)
🏢 NAVKIRAN FOUNDATION
📍 Baddi