What are the responsibilities and job description for the Senior Quality Assurance Specialist position at Glenmark Pharmaceuticals USA?
Company Overview
Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules. As a fast-growing and robust US generics business, we plan to move into the innovative market.
Job Description
- Perform quality control analysis in compliance with cGMP standards prescribed by USFDA.
- Maintain data integrity and compliance in the QC lab according to USFDA standards.
- Perform instrument qualification and calibration in the QC lab under the guidance of CQA.
- Execute procedures and systems for raw materials, packaging materials, finished products, and in-process testing in the QC lab.
- Provide information and data for stability study evaluation and execution according to quality and regulatory requirements.
- Complete testing on time and ensure compliance during analytical TT and AMV performed in the QC lab.
Required Skills and Qualifications
- Bachelor's degree in Chemistry or Pharmaceutical Sciences.
- 4 years of experience in pharmaceutical manufacturing facilities, preferably in Quality Control.
- Background in Stability, Finished Goods, and Raw Materials with some experience in Analytical R&D.
- Extensive knowledge of general laboratory equipment, including GC, HPLC, Polarography, Particulate Matter, UV-Vis, and FTIR.
