Job Description:

Key Responsibilities:

1. Method Development & Validation

- Develop analytical methods for assay, dissolution, related substances, and stability testing.

- Conduct method validation as per ICH guidelines (accuracy, precision, specificity, linearity, robustness).

- Optimize and troubleshoot existing analytical methods.

2. Instrument Handling

- Operate analytical instruments such as HPLC, GC, UV, FTIR, KF, Dissolution Apparatus, etc.

- Perform daily calibration and ensure instrument readiness.

3. Stability Studies

- Analyze stability samples as per stability protocols.

- Prepare stability reports and data interpretation.

4. Documentation & Reporting

- Prepare and maintain method development reports, validation protocols, COAs, raw data.

- Ensure compliance with cGMP, GLP, ALCOA+ and regulatory guidelines.

5. Support to Formulation Development

- Provide analytical support during R&D; trials, scale-up, exhibit batches, and technology transfer.





- Evaluate prototype formulations using analytical parameters.

6. Regulatory Support

- Prepare analytical documents for ANDA, DMF, CTD submissions.

- Support responses to regulatory queries related to analytical methods.

7. Lab Compliance

- Maintain lab safety, instrument calibration, reagent management, and SOP adherence.

- Participate in internal audits and ensure continual improvement.

Desired Profile / Criteria / Skills :

Required Skills & Qualifications

- B.Sc / M.Sc (Chemistry) or B.Pharm / M.Pharm

- 1–8 years experience in ADL (Formulation)

- Strong knowledge of HPLC/GC method development, ICH guidelines, R&D; support

- Positive understanding of analytical chemistry and pharma regulations

- Proficiency in documentation and data integrity practices

📌 Analytical Development Laboratory (ADL) For Pharmaceutical Company (Amreli)
🏢 Pramukh Staffing
📍 Amreli