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 Valuable 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.

📌 Officer / Executive - Stability Analysis (Quality Control) - Pithampur
🏢 Rubicon Research
📍 Pithampur