Key Duties and Responsibilities
Sciom Limited, founded in 2023, aims to provide unparalleled quality control and microbiology services to the pharmaceutical and biosciences industry.
The role involves performing release and stability testing of QC samples, raw materials, and finished products using HPLC, GC, UV, FTIR, Dissolution, and Karl Fischer analysis, with proper documentation and adherence to Good Documentation Practices.
Responsibilities include testing bulk physical parameters for tablets, capsules, and finished products against specifications, developing and validating analytical methods compliant with pharmacopeial standards, and trend analysis of QC results to investigate OOT/OOS issues according to SOPs.
The role also involves updating documentation and laboratory systems, preparing mobile phases and reagents, writing reports and SOPs, calibrating and maintaining analytical instruments, and performing microbiological testing such as organism identification, media fills, bioburden, sterility, and endotoxin tests.
Additional duties may be assigned as required.
Essential Experience, Skills, and Abilities
- Relevant degree in a scientific discipline
- Previous laboratory experience, especially with HPLC analysis and troubleshooting
- Understanding of GMP and pharmacopeial standards
- Experience working in the pharmaceutical industry following SOPs
- Proficient in Microsoft Office (Word and Excel)
- Knowledge of GMP, ICH guidelines, BP/EP/USP methods, and QA processes
- Methodical work approach and ability to meet tight deadlines
- Hands-on experience with instrumentation such as HPLC, GC, Dissolution, UV, FTIR in a cGMP environment
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