Excellent knowledge of GLP’s, ICH guidelines, FDA and HC regulations. Test products on daily basis as per customers specifications.
Able to prepare OOS and OOT reports.
Perform all instrumental and wet chemistry analysis following specified analytical methods and produce accurate results in a timely manner.
Maintain all lab records per GMP- GLP and customer requirements. Maintain accuracy and reliability of all laboratory instruments.
Review and assess analytical methods for compatibility and capability.
Conduct method transfers from customer or for internal purposes.
Monitor Stability chambers daily and report any excursions.
HPLC and GC experience with testing accelerated Stability Studies.
The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills.
Other duties may be added, or this description amended at any time.
Bachelor degree (or higher) required in area of discipline