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 qualified who can maintain the highest standards of data integrity, laboratory compliance, and scientific excellence while collaborating closely with cross functional teams to support product development and quality assurance activities.

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.

Laboratory Inventory Management

- Maintain inventory of laboratory chemicals, reagents, glassware, consumables, and laboratory aids.
- Raise Purchase Requisitions (PRs) for laboratory consumables, chemicals, spare parts, and equipment.
- Monitor laboratory inventory levels to ensure uninterrupted analytical operations.

Cross-Functional Collaboration

- Collaborate with Quality Assurance, Production, R&D;, Regulatory Affairs, and Purchase teams to support analytical requirements.




- Support investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviations.
- Contribute to process improvements that enhance laboratory efficiency and data integrity.

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

· Working Standards & Reference Standards Management

· Data Analysis & Trend Analysis

· Investigation of LIR, OOS & OOT

· Laboratory Inventory Management

· Scientific Report Writing

· Attention to Detail

· Cross-functional Collaboration

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.

Experience Freshers with good knowledge of Analytical instruments like HPLC, GC, FTIR & UV Spectroscopy.

Compensation & Benefits

- Industry-aligned salary package with performance-linked growth opportunities.
- Performance-based incentives
- Opportunities to work on challenging projects, new technologies, and industry-relevant initiatives.
- Career growth opportunities within a rapidly expanding global organization
- Opportunity to work with an industry-leading pharmaceutical company serving customers across more than 90 countries.

Work Location: In person

📌 ADL Officer (Vasai-Virar)
🏢 Simson Pharma
📍 Vasai-Virar