Job Description:

Key Responsibilities:

1. Method Development & Validation

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

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

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Optimize and troubleshoot existing analytical methods.

2. Instrument Handling

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

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Perform daily calibration and ensure instrument readiness.

3. Stability Studies

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Analyze stability samples as per stability protocols.

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Prepare stability reports and data interpretation.

4. Documentation & Reporting

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

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

5. Support to Formulation Development

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





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Evaluate prototype formulations using analytical parameters.

6. Regulatory Support

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Prepare analytical documents for ANDA, DMF, CTD submissions.

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Support responses to regulatory queries related to analytical methods.

7. Lab Compliance

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

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Participate in internal audits and ensure continual improvement.

Desired Profile / Criteria / Skills :

Required Skills & Qualifications

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

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1–8 years experience in ADL (Formulation)

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

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Good understanding of analytical chemistry and pharma regulations

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Proficiency in documentation and data integrity practices

📌 Analytical Development Laboratory (Amreli)
🏢 Pramukh Staffing
📍 Amreli