What are the responsibilities and job description for the Regulatory Compliance Specialist position at Glenmark Pharmaceuticals?
Job Details
We are seeking a highly skilled Senior Quality Control Analyst to join our team at Glenmark Pharmaceuticals Inc., USA.
Responsibilities
- 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.
Requirements
- 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.
