Senior Research Analyst

a. Development/Routine/initial/stability analysis for development batches

1. Literature survey.

2. To perform stability/initial sample analysis and clearly document results and present for checking and review.

3. To suggest if any changes are necessary in methods with supporting records.

4. To report correct results and minimize repeat analysis by eliminating personal errors.

5. To report immediately abnormalities and out of trend results.

6. Sample disposal after analysis.

b. Analysis for analytical method validations, method transfer and deficiencies from regulatory agencies, Standard generation

1. Analytical method development for all analytical methods e.g. particle size, Assay, Related substances, Dissolution etc.

2. Analytical method validation for all analytical methods e.g. particle size, Assay, Related substances, Dissolution etc.

3. Analytical method transfer for all analytical methods e.g. particle size, Assay, Related substances, Dissolution etc.

4. Protocols, report preparation for method validation and transfer.

5. Analysis for standard generation.

6. Analysis for deficiency response.

c. Reporting of analytical data and data management

1. To submit analytical raw data (Laboratory notebook, chromatograms, calculation sheet etc.) for supervisors review, immediately after completion of reporting.

2. To avoid repeat analysis.

3. To report incident / investigation, out of specification (OOS), out of acceptance criteria (OAC) results, deviation.

d. Resource management

1. To ensure the utilization of chemicals, solvents and consumables in economical manner.

2. To suggest measures if any to reduce cost of operations.

3. HPLC column regeneration, as per requirement.

e. cGMP compliance, Training and contribution towards department goals

1. To perform calibration for instrument and updation of instrument status board.

2. To fill and report breakdown related to instrument and maintain records of breakdown and service.

3. Adherence to cGMP requirements during execution of all analytical activities.

4. To make entries in instrument log books.

5. To make entries in logbooks for innovator samples consumptions, in-house reference standard, working standards and Pharmacopoeia standards.

6. SOP preparation, update and adherence to SOP.