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Job Description

Role and Responsibilities

The primary purpose of the job is to perform the testing and decides on the acceptability of the process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment in support of the timely disposition of manufactured products. Analyze and interpret results in written and oral format.

Perform routine release tests of raw materials and finished products including wet chemistry analysis, dissolution, content uniformity, assay, particle size distribution, density, water determination by KF, and other tests according to the in-house specifications and methods and USP monographs using classical wet chemistry and instrumental techniques.
Perform routine tests like assays, related compounds, chromatographic purity, residual solvents, particle size distribution, Infra-red spectroscopy using different techniques and instrumentation like UV, HPLC, GC, IR etc.
Evaluates test results and decides acceptability of the samples based on the test results. Reviewing and releasing of 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

Qualification and Experience

Qualifications and Education Requirements

Bachelor's Degree in Chemistry or related scientific field and 2+ years' industry experience as a Chemist
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.
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.
Knowledge of basic to advance level of computer skills.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

Competencies

Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility