Officer / Executive - Stability Analysis (Quality Control) - Pithampur

Rubicon Research; Pithampur; On-site; INR 600,000 - 900,000; Full time

Job summary

Rubicon Research in India seeks a stability testing specialist to perform physical, chemical, and instrumental testing of stability samples in strict adherence to cGMP, GLP, and stability guidelines. You will generate accurate shelf-life data and support regulatory submissions at the manufacturing site.

Key duties include routine analyses on HPLC, GC, UV-Vis, FTIR, and dissolution; maintaining GDP-compliant records; and collaborating with QA to prepare data for audits by USFDA/MHRA.

Qualifications

• Experience with stability analysis and stability guidelines (ICH).
• Proficient in operation of HPLC and GC instruments.
• Knowledge of GDP and data integrity principles.
• Experience with regulatory audits (USFDA/MHRA) preferred.
• Able to work across all rotational shifts.

Responsibilities

• Perform routine physical, chemical, and instrumental testing of stability samples at designated time intervals according to the Stability Master Plan.
• Execute high-precision testing on instruments including HPLC, GC, UV-Vis, FTIR, and dissolution apparatus.
• Monitor and maintain stability study protocols, pull schedules, and ensure timely sample withdrawal from stability chambers.
• Document all analytical data, chromatograms, and calculations in real-time adhering to GDP.
• Support laboratory investigations related to Out of Trend (OOT) and Out of Specification (OOS) results.
• Assist in validation, verification, and technical transfer of analytical stability testing methods.
• Perform routine instrument calibrations and ensure qualification of working standards.
• Enforce GLP and data integrity across automated chromatography systems.
• Maintain stability documentation for regulatory audits (USFDA/MHRA).
• Coordinate with QA to ensure data submission for annual product reviews and filings.
• Adhere to Health, Safety, and Environment regulations on laboratory floor.
• Be flexible to work across all rotational shifts.

Skills

Chromatography Operation

Stability Testing Workflows

Pharma Software Platforms

QMS & Trend Awareness

Data Integrity & Comms

Education

Bachelors/Master’s in Science or Pharmacy with chemistry background

Tools

Chromeleon 7.2

Job description

Role & responsibilities

Purpose

To perform physical, chemical, and instrumental testing of stability samples in strict compliance with cGMP, GLP, and stability guidelines. This role ensures accurate shelf-life data generation, tracks stability chamber storage parameters, and supports regulatory submission timelines for formulation products at the manufacturing site.

Responsibilities

• Perform routine physical, chemical, and instrumental testing of stability samples at designated time intervals according to the Stability Master Plan.
• Execute high-precision testing on modern analytical laboratory instruments including HPLC, GC, UV-Vis, FTIR, and Dissolution apparatus.
• Monitor and maintain stability study protocols, pull schedules, and ensure timely sample withdrawal from stability chambers.
• Document all analytical raw data, chromatograms, and calculation sheets in real-time, adhering strictly to Good Documentation Practices (GDP).
• Support laboratory investigations related to Out of Trend (OOT) and Out of Specification (OOS) results observed during stability testing.
• Assist in the validation, verification, and technical transfer of analytical stability testing methodologies.
• Perform routine instrument calibrations and ensure the qualification of working standards used during stability runs.
• Enforce absolute compliance with Good Laboratory Practices (GLP) and current Data Integrity principles across automated chromatography systems.
• Maintain complete stability documentation and logbooks in a perpetual state of readiness for international regulatory audits (USFDA/MHRA).
• Coordinate cross-functionally with the Quality Assurance team to ensure prompt data submission for annual product reviews and regulatory filings.
• Maintain strict adherence to internal Health, Safety, and Environment (HSE/EHS) regulations on the laboratory floor.
• Demonstrate flexibility to work across all rotational shifts and complete tactical analytical tasks distributed by the QC Supervisor or HOD.

Required Skills

• Chromatography Operation: Strong hands‑on proficiency in operating, running, and basic troubleshooting of HPLC and GC systems.
• Stability Testing Workflows: Clear understanding of ICH stability guidelines, stability parameters, pull schedules, and dissolution profiling.
• Pharma Software Platforms: Practical working knowledge of chromatography software data platforms, with an advantage given to Chromeleon 7.2 software.
• QMS & Trend Awareness: Basic understanding of checking data for Out of Trend (OOT) profiles and participating in laboratory incident reports.
• Data Integrity & Comms: Adequate written and verbal communication skills required to track complex logbooks and report data clearly.

Preferred Candidate Details

• Education: Regular Bachelors or Master’s Degree in Science (B.Sc / M.Sc) or Pharmacy (B.Pharm / M.Pharm) with a chemistry background.
• Experience Range: 2 to 7 years of core analytical testing experience focused specifically on Stability Analysis within a regulated pharma laboratory.
• Dosage Form Exposure: Direct testing experience handling formulation matrix types across Solid Orals, Nasal sprays, or Liquids.
• Regulatory Exposure: Past working experience within a USFDA/MHRA-approved formulation manufacturing facility is highly preferred.
• Operational Readiness: Complete willingness to work across all rotational shifts based on site sample volumes and business priorities.