Job Description
This position is responsible for performing analytical testing and analysis of biopharmaceutical drug substance, drug products, and raw Training SOP for training and training records.
- Execute and perform testing as per methods independently, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.
- Keep all records and notebooks in good order. Prepare reports and record data in timely manner.
- In case of a testing failure, immediately report to the Supervisor / Department Head before proceeding further with the test.
Assist in the failure investigations.
- Assist to prepare method SOP, validation protocol and validation report, and perform validation experiments.
- Assist to trouble-shoot test methods / instruments.
- Ensure that work order documentation is complete in every respect and all results are entered into Electronic Laboratory Information System or client’s Certificate of Analysis before submission to the QA reviewer.
Qualifications
- Minimum of BSc / MScin a relevant field with 3 to 5 year of relevant laboratory work experience required.
- Knowledge of techniques in a biotechnology discipline, appearance (EP , EP , Microflow Flow Imaging, Dynamic Light Scattering, Particulate Matter, Water Content, UV / VS Spectrophotometry, pH, Osmality
- Ability to perform routine bench and instrumental analysis including ability to understand assay methods.
- A willingness to learn new analytical tests, instrumentation and procedures.
- Experience in computer programs Excel and Word.
- Able to work well under pressure during high (peak) work loads and balancing conflicting demands of high volume versus the quality of results.
- Extended hours and shift work is required.
Analyst, Biotech Level 1 - Compendial
Knowledge of techniques in a biotechnology discipline, e. ...
Analyst, Biotech Level 1 - Compendial
Knowledge of techniques in a biotechnology discipline, appearance (EP , EP , Microflow Flow Imaging, Dynamic Light Scattering, Particulate Matter, Water Content, UV/VS Spectrophotometry, pH, Osmality. ...
Analyst, Biotech Level 1 - Compendial
Knowledge of techniques in a biotechnology discipline, e. ...
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