Job Description:

Key Responsibilities:
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.
Instrument Handling
Operate analytical instruments such as HPLC, GC, UV, FTIR, KF, Dissolution Apparatus, etc.
Perform daily calibration and ensure instrument readiness.
Stability Studies
Analyze stability samples as per stability protocols.
Prepare stability reports and data interpretation.
Documentation & Reporting
Prepare and maintain method development reports, validation protocols, COAs, raw data.
Ensure compliance with cGMP, GLP, ALCOA+ and regulatory guidelines.
Support to Formulation Development
Provide analytical support during R&D; trials, scale-up, exhibit batches, and technology transfer.




Evaluate prototype formulations using analytical parameters.
Regulatory Support
Prepare analytical documents for ANDA, DMF, CTD submissions.
Support responses to regulatory queries related to analytical methods.
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)
Solid 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 Amreli
🏢 Pramukh Staffing
📍 Amreli