SimSon Pharma Limited
Website:
simsonpharma.com
Job details:
ADL Officer
Location - Mumbai
About Simson Pharma Limited
Simson Pharma Limited is a globally recognized pharmaceutical company specializing in the manufacturing and supply of pharmaceutical reference standards, impurities, metabolites, stable isotope-labelled compounds, nitrosamines, and advanced research chemicals. Serving customers across more than 90 countries, we are committed to delivering innovation, uncompromising quality, and operational excellence to the global pharmaceutical and research community.
Job Summary
We are looking for a skilled ADL Officer to support the analytical development and quality evaluation of pharmaceutical products for both domestic and international markets. The ideal candidate should possess strong expertise in analytical chemistry, laboratory instrumentation, method validation, documentation, and regulatory compliance while ensuring accurate and timely analysis of pharmaceutical materials. The role requires a detail-oriented professional who can maintain the highest standards of data integrity, laboratory compliance, and scientific excellence while collaborating closely with crossfunctional teams to support product development and quality assurance activities.
Experience
3 - 4 years of experience in an Analytical Development Laboratory (ADL), or related analytical function within the pharmaceutical industry.
Key Responsibilities
Analytical Testing & Laboratory Operations
- Perform analysis of drug substances and drug products in accordance with approved Standard Test Procedures (STPs).
- Conduct chemical assays, reagent standardization, and analytical testing using validated analytical methods.
- Prepare analytical reports, Certificates of Analysis (CoA), and laboratory documentation with complete accuracy.
- Perform trend analysis of analytical data and report observations to the management.
Instrument Operation & Maintenance
- Operate, calibrate, verify, and troubleshoot laboratory analytical instruments, including HPLC, GC, FTIR, UV-Visible Spectrophotometer, Viewing Cabinet (UV Light), Refractometer, Vacuum Oven, Water Bath, Vacuum Pump, Moisture Analyzer, Magnetic Stirrer, Conductivity Meter, TOC Analyzer, Muffle Furnace, TLC Chamber, Humidity Chamber, Water Purification System
- Ensure all instruments remain calibrated and maintained in accordance with GMP requirements.
- Maintain complete calibration, maintenance, and qualification records.
Method Development & Validation
- Perform method verification and analytical method validation as per regulatory guidelines.
- Investigate laboratory errors, deviations, and Laboratory Investigation Reports (LIRs).
- Support continuous improvement of analytical methods and laboratory processes.
- Assist in troubleshooting analytical issues and implementing corrective actions.
Laboratory Documentation & Compliance
- Prepare, review, and update departmental SOPs.
- Prepare, review, and maintain Working Standards and Reference Standards.
- Ensure laboratory activities comply with GMP, GLP, and internal quality standards.
- Maintain accurate documentation for audits and regulatory inspections.
Required Skills
- Pharmaceutical Analytical Testing
- HPLC, GC, FTIR & UV Spectroscopy
- Analytical Method Validation & Verification
- Instrument Calibration & Troubleshooting
- GMP & GLP Compliance
- Chemical Assays & Reagent Standardization
- Laboratory Documentation & SOP Preparation
- Scientific Report Writing
Qualification
- M.Sc. in Chemistry (Organic, Analytical, Pharmaceutical, or related specialization)
- Additional qualification in Quality Management, Analytical Sciences, or Pharmaceutical Quality will be an added advantage
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