Job Purpose:
- Perform routine testing and decides on the acceptability of the in-process, process validation samples, raw materials, packaging materials, finished products, stability samples and developmental samples in a regulated laboratory environment.
- Analyze and interpret results in written and oral format.
Duties and Responsibilities
- Perform routine tests of Raw materials, Packaging materials, In-process and Finished products and stability samples including wet chemistry analysis, dissolution, content uniformity, assay, particle size distribution, density, water determination by KF, and other tests according to the in-house monographs and USP using classical wet chemistry and instrumental (HPLC, GC, etc).
- Evaluates test results and decides acceptability of the samples based on the test results.
- Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
- Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
- Ensure notebooks are reviewed in a timely manner, in accordance with SOPs.
- Writes or revise test procedures, protocols, SOPs, based on the outcome of the experimental design.
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices
Educationand/or Experience:
- Bachelor's degree in Chemistry or Pharmacy or related scientific field with minimum 4 to 8 years' experience in Pharmaceutical analysis or Master's degree in Chemistry or Pharmacy or related scientific field with minimum 4 to 8 years' experience in Pharmaceutical analysis.
- Clear understanding of normal, molar and percent concentrations. Ability to prepare solutions according to a required concentration.
- Ability to deal with problems involving several concrete variables in standardized situations.
Must have Valid work permit.