Role & responsibilities
- Perform analytical testing of CRMs for property value assignment, purity, identity, assay, and related substances using HPLC, LC-MS, GC-MS, FT-IR, UV-Visible spectrophotometry, moisture content by Karl Fischer (KF), and inorganic content by TGA
- Execute and review homogeneity and stability study designs, statistical evaluations, and shelf-life assignment of CRMs as per approved protocols
- Ensure metrological traceability of all measurements; approve calibration strategies, reference standard sourcing, and measurement uncertainty calculations
- Perform analytical method validation/verification (specificity, linearity, accuracy, precision, LOD, LOQ, robustness) per ICH Q2(R2)
- Calculate assigned values and evaluate measurement uncertainty; generate and review analytical data and technical reports supporting Certificate of Analysis (CoA) preparation
- Generate, review, and maintain analytical data with complete traceability per ISO data integrity principles
- Maintain and periodically review SOPs, test methods, specifications,



and controlled documents under the quality management system
- Maintain system suitability, instrument logbooks, and calibration records; oversee instrument qualification (IQ/OQ/PQ), preventive maintenance programs, and vendor management for analytical equipment
- Ensure laboratory operations comply with ISO 17034, ISO/IEC 17025, data integrity, GLP/GMP, and applicable ISO requirements
- Evaluate non-routine test methods, non-conformities, and root cause analyses
- Lead non-conformity handling, corrective action implementation, change control, and risk-based decision making within the testing function
- Participate in internal audits, proficiency testing, inter-laboratory comparisons, method performance monitoring, and internal quality check programmes such as blind testing and replicate testing as per ISO 17025 requirements

Preferred candidate profile

Requirements
- M.Pharm or M.Sc in Analytical Chemistry from a re

📌 Research Scientist (Ahmedabad)
🏢 Probus Standards
📍 Ahmedabad