Chemist B

Chemist B is responsible for ensuring that products and materials meet established quality standards and regulatory requirements by conducting laboratory tests, analyzing results, and maintaining accurate documentation. They perform testing on raw materials, in-process samples, and finished goods using various analytical techniques, while adhering to standard operating procedures (SOPs), Standard test procedure and Good Manufacturing Practices (GMP). QC Analysts also investigate discrepancies such as out-of-specification results, support corrective actions, maintain laboratory equipment, and ensure compliance with regulatory guidelines. This role requires strong attention to detail, technical expertise, and the ability to work in regulated environments.

1. Perform physical, chemical and instrumental tests on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
2. Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
3. Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.
4. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
5. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
6. Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training.
7. Perform troubleshooting and investigations under the direction of a supervisor.
8. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
9. Review of Analytical documents as required
10. Minimum 3-5 years experience in pharmaceuticals and must have 2-4 year experience in Analytical testing
    • Experience in Generic Pharmaceutical industries would be preferable
    • Knowledge in Good Documentation practices.
    • Knowledge in USP/ICH/FDA
    • Ability to learn quickly and decision making skills
    
    
    Other duties as assigned
11. Minimum BS with Scientific field
12. BS with Chemistry is one of the subjects preferred