Bio Chemist Job in Granules India Limited

Job Summary

The role of QC Biochemist/chemist II is responsible for supporting the operations and manufacturing process by performing routine and non-routine analytical testing raw materials, in-process, finished formulations, stability samples, method development and/or transfers, and cleaning validations. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Responsible for the safe and efficient execution of job duties

Principle Accountabilities

JOB DUTIES & RESPONSIBILITIES:

• Conduct routine analytical testing of raw materials, packaging materials, finished product release and stability using approved methods and various instrumentation (HPLC, Dissolution apparatus,UV-Vis, FT-IR and KF Auto titrator) while adhering to cGMP and established policies.
• Perform routine cleaning method validation/verification under the supervision.
• Perform routine analytical balances daily verification and standardization of Karl fisher for water content determination.
• Prepares necessary reagents (Mobile phase, Dissolution mediums) and Set-up the analytical equipments (HPLC, Dissolution baths) for routine testing.
• Compile laboratory test data and perform appropriate analyses that include physical (solubility, viscosity), chemical (titration) and analytical (FTIR, HPLC, UV-Vis, KF) testing etc.
• Complete documentation needed to support testing procedures including test forms and logbooks.
• Interpret test results, compare them to established specifications and control limits, and ensure appropriateness of data for release. Treats data with a high level of integrity and ethics.
• Participate in out-of-specification and failure investigations. Support all aspects of laboratory investigations
• Provide general laboratory support; such as routine instrument cleaning/preventive maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.

Management Responsibility

NA

Reports to

Team lead or designee of Analytical Laboratory.

Internal/External Contacts

Yes

Knowledge & Skills

Preferred:

Strong knowledge of the major analytical techniques: HPLC/UPLC, GC, dissolution, FT-IR, etc. Strong knowledge of FDA/ICH regulations.

Experience & Education

BS Chemistry or science related field. Minimum of one (1) year experience in using analytical instrument techniques (HPLC,FT-IR, UV-Vis, Dissolution Apparatus, Ovens/Auto Titrators/KF Titrator, etc.).

Physical Requirements/Working Environment

• Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
• Commitment to long hours of work when necessary to achieve goals.
• Respirator, lab coat and safety glasses required. Ability to work with potent substances using a glove-box.

Travel

No Travel requirement.