Quality Control Chemist

Quality Control Chemist

The Quality Control Chemist for the drug product testing reports to the Finished Product/Stability Supervisor. The primary purpose of the job is to perform testing and make calculated decisions on the acceptability of process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment in support of timely disposition of manufactured products.

Essential Duties and Responsibilities:

• Perform routine stability tests using stability indicating methods including dissolution, assay, related compounds, chromatographic purity etc. Additionally, individual shall be aware of commonly used wet analysis techniques, particle size distribution, density, water determination by KF, and other tests to perform test according to the in-house specifications and methods and USP monographs using classical wet chemistry and instrumental techniques.
• Follow written operating procedures to perform routine tests like dissolution, assays, blend uniformities, related compounds, chromatographic purity, residual solvents, particle size distribution, Infra-red spectroscopy using different techniques and instrumentation like Dissolution, UV, HPLC, GC, IR etc.
• Evaluate test results and decide acceptability of the samples based on the test results. Review and release the raw data, documentation and results for certificate of analysis.
• Write draft technical documents like specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports etc.
• Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
• Follow SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices. Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
• Other duties related to departmental activities may be assigned by management based on situation and necessity.

Education & Experience:

Bachelor's Degree in Chemistry or related scientific field and 3+ years' industry experience as a Chemist or Master's Degree in Chemistry or related scientific field and 1+ years' industry experience as a Chemist. Knowledge of current GMP guidance, applicable USFDA and ICH guidelines and regulatory requirements (such as USP/ICH requirements). Ability to make observations with instruments and analysis techniques. Basic knowledge of instrument techniques and software for instruments like HPLC, GC, IR, KF, metrohm titrator, etc.

Previous experience with Empower is plus. Ability to carry out necessary computations and to draw and interpret graphs. Basic knowledge of method validation, method transfer and method verification of the analytical methods.