Our pharmaceutical client is looking for some chemists to join their growing organization! If you are someone who wants to be a part of a highly technical team, this may be the role for you!
- Review data for compliance to specifications; document and investigate nonconformities
- Perform Routine Commercial Product Release and Stability Testing
- Ensure Good Documentation Practices for relevant QC testing procedures, and that documents are current and accurately and clearly describe processes, reagents, and acceptance criteria
- Perform routine release testing of raw materials (Active ingredient, excipients, colors,) and packaging materials in accordance with established procedures (in-house, Pharmacopeial, vendor procedures)
- Perform routine tests as assays, related compounds, chromatographic purity, residual solvents, particle size distribution, Infrared spectroscopy using different techniques and instrumentation like FTIR, UV, HPLC, UPLC, GC, etc.
- Perform routine wet chemistry analysis as titrations, water content, specific rotation, melting point, identification tests, viscosity, density, LOD, LOI, ROI etc. as per respective monographs and established procedures in a regulated laboratory environment.
- Evaluates test results and determines acceptability of the data based on acceptance criteria. Reviewing and releasing of the raw data, documentation and results for certificate of analysis.
- Writing 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 maintain proper GMP documentation in compliance with SOPs.
- Design and develop test methods, perform experimental tests and evaluate performances of test methods. Establish test specifications, communicates with internal and external customers.
- Follow all 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
Qualifications:
- BS/MS in Chemistry
- 1+ years relevant quality control experience Preferred
- Laboratory experience with a variety of analytical techniques including, but not limited to, GC,UV,HPLC, IR
- Proficient in general and non-routine laboratory skills
