Officer - Analytical Method Validations - Pithampur

Role & responsibilities

Purpose

To perform physical, chemical, and instrumental testing dedicated to analytical method validation, verification, and transfer activities in strict compliance with cGMP, GDP, and GLP standards. This role manages technical protocols, instrument calibrations, and cross-functional coordination with development teams to ensure seamless method lifecycles at the plant.

Responsibilities

• Perform precise physical, chemical, and instrumental analysis related directly to analytical method validation, verification, and method transfer activities.
• Execute high-precision analytical runs using core laboratory instruments including HPLC, GC, UV-Vis, FTIR, and Dissolution apparatus.
• Draft, review, and compile technical documentation including validation protocols, verification plans, and detailed technical summary reports.
• Coordinate directly with the Analytical Development (ADL) team to troubleshoot deviations or discrepancies observed during method transfer phases.
• Perform routine calibration of instruments and execute the qualification of working standards in strict accordance with site SOPs.
• Provide flexible cross-functional support to routine Quality Control analysis workflows whenever high sample volumes require it.
• Ensure strict adherence to Good Laboratory Practices (GLP) and current Data Integrity principles during all data recording steps.
• Maintain a perpetual state of inspection readiness for all method validation dossiers during international regulatory audits.
• Adhere strictly to internal Health, Safety, and Environment (HSE/EHS) guidelines and laboratory safety practices on the floor.
• Demonstrate self-driven execution capabilities to complete deliverable validation tasks on time with minimal supervision.
• Provide total flexibility to work in all rotational shifts and travel across various plant locations based on business priorities.
• Execute additional analytical testing and operational tasks assigned by the supervisor or HOD as per business requirements.

Required Skills

• Method Transfer & Validation: Clear technical understanding of validation parameters (linearity, accuracy, precision) and cross-site method verification workflows.
• Instrument Expertise: Strong hands-on experience operating, setting up, and troubleshooting HPLC, GC, Dissolution, and Karl Fischer (KF) techniques.
• Pharma Software Mastery: Practical working knowledge of modern chromatography data platforms, with specific advantage given to Chromeleon 7.2 software.
• Technical Writing: Strong capability to compile raw analytical data into formal, compliant validation protocols and transfer dossiers.
• Cross-Functional Comms: Good written and verbal communication skills needed to coordinate smoothly with ADL, QC, and external audit teams.

Preferred Candidate Details

• Education: Regular B.Sc. / M.Sc. in Science or B.Pharm / M.Pharm or equivalent technical qualification.
• Experience Range: Mid-level analytical testing experience focused specifically on Method Validation / Method Transfer (MV/MT) inside a pharma lab.
• Regulatory Environment: Proven background working within a USFDA-approved manufacturing site under rigid GLP, GDP, and GMP controls.
• Operational Flexibility: Complete willingness to work across all rotational shifts based on project timelines and validation schedules.
• Mobility Readiness: Total flexibility to travel to different plant locations on work priority as per company policies.