Routinely performs work-flow processes within the quality control laboratory to meet customer requirements by supporting the testing of raw materials and finished products while ensuring regulatory compliance standards are met.
Perform qualitative, quantitative chemical and physical testing and as specified by compendia or specification for API's, starting materials, packaging components and finished products
Perform peer review of analytical testing documentation and resolve discrepancies
Complete and/or conduct required training according to the laboratory curriculum
Maintain laboratory data in an orderly manner in laboratory notebooks, worksheets and documents
Re-validate microbiological methods
Author technical reports for analytical methods improvement.
Perform investigations and advanced analytical techniques to troubleshoot approved commercial analysis.
All other duties as assigned
Bachelor's in Chemistry or in a science-related field or equivalent. Three to five years pharmaceutical experience preferred.
The work related experiences required include the execution of analytical methods, with supervision for evaluation and release of Active Pharmaceutical Ingredients (APIs) or Pharmaceutical products. The colleague must be able to perform compendia and non-compendia testing for multiple projects at one time. Experience with Empower data analysis software is desirable.
Experience with the following analytical techniques is required:Additional experience with the following analytical techniques are highly desired:
For APIs: Arsenics, UV, HPLC
For Pharmaceutical products: UV, HPLC, dissolution
Additional experience with the following analytical techniques are highly desired:
For APIs: GC, DSC, TGA, particle size, microscopy
For Pharmaceuticals: GC, AA, IR
Knowledge of the critical functions/variables for each type of equipment is also highly desired as well as instrument trouble-shooting ability.
Must be able to work independently using a team approach to accomplish tasks assigned. Must possess the ability to work on multiple projects in a fast pace environment.
Must possess good written and verbal communication skills
Notification to Agencies
Please note that Hikma does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, Hikma will not consider or approve payment to any third-parties for hires made.