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 recognised university (mandatory for this role); alternatively B.Sc (Chemistry) with 79 years of progressive analytical experience
- 46 years of hands-on experience in an analytical laboratory (pharma QC, R&D;, or testing lab)
- Strong proficiency in HPLC (mandatory); working experience with LC-MS, GC-MS, FT-IR, UV-Vis, KF and TGA
- Experience with analytical method validation per ICH guidelines
- Knowledge of measurement uncertainty evaluation and statistical data analysis
- Familiarity with ISO/IEC 17025 or ISO 17034 quality systems is a significant advantage
- Experience with non-conformity handling and corrective action implementation processes
- Ability to review and author SOPs, test methods, and technical reports
- Robust communication skills; professional proficiency in English
- Willingness to work at our Changodar (Ahmedabad) laboratory facility

What We Offer

- Opportunity to be part of a pioneering organisation in Indias CRM industry — early team members will play a foundational role in the company’s growth
- Direct exposure to NABL-accredited laboratory operations and ISO 17025/17034 quality systems
- Hands-on, high-responsibility role from day one — no waiting years for meaningful work
- Clear career growth path as the company scales
- Supportive, small-team environment with direct access to leadership

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