Officer - Analytical Method Validations - Pithampur

Rubicon Research; Pithampur; On-site; INR 600,000 - 800,000; Full time

Job summary

Rubicon Research in India (Pithampur) seeks a hands-on analytical professional to perform physical, chemical, and instrumental testing for analytical method validation, verification, and transfer activities in a cGMP/GDP/GLP environment.

You will operate HPLC, GC, UV-Vis, FTIR, and dissolution equipment, draft validation protocols, coordinate with the ADL team, ensure data integrity, and support QC during high volumes. Willingness to work rotating shifts and travel to plant locations is required.

Qualifications

• Clear technical understanding of validation parameters (linearity, accuracy, precision) and cross-site method verification workflows.
• Hands-on experience operating HPLC, GC, Dissolution, and KF techniques.
• Knowledge of chromatography data platforms, with Chromeleon 7.2 being a plus.
• Ability to compile raw analytical data into formal validation protocols and transfer dossiers.
• Strong written and verbal communication for cross-functional teams.

Responsibilities

• Perform physical, chemical, and instrumental analysis for method validation, verification, and transfer.
• Operate core lab instruments including HPLC, GC, UV-Vis, FTIR, and Dissolution apparatus.
• Draft, review, and compile validation Protocols, verification plans, and technical summary reports.
• Coordinate with Analytical Development (ADL) team to troubleshoot deviations during method transfer.
• Calibrate instruments and qualify working standards per site SOPs.
• Provide cross-functional support to QC analyses during high sample volumes.
• Ensure GLP and data integrity in all data recording steps.
• Maintain inspection readiness for method validation dossiers during regulatory audits.
• Adhere to HSE/EHS guidelines on the floor.
• Be flexible to work across rotational shifts and travel to different plant locations.

Skills

Method Transfer & Validation

Instrument Expertise

Pharma Software Mastery

Technical Writing

Cross-Functional Comms

Education

B.Sc. / M.Sc. in Science or B.Pharm / M.Pharm

Tools

HPLC

GC

Dissolution

Karl Fischer (KF)

Chromeleon 7.2

Job description

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.