Key Responsibilities:
Analysis of Samples: Perform analytical tests on raw materials, intermediates, and finished products using wet and instrumental techniques.
Documentation and Reporting: Maintain accurate records of analysis, prepare reports on QC performance, and document deviations.
Calibration and Validation: Ensure the proper calibration and validation of analytical instruments.
Stability Studies: Conduct and interpret stability studies to determine the shelf life of products.
GMP Compliance: Adhere to cGMP guidelines and maintain a clean and organized working environment.
Troubleshooting: Troubleshoot analytical issues and ensure the smooth functioning of QC operations.
Collaboration: Work closely with other departments like Production, R&D, and Regulatory Affairs to ensure seamless QC processes.
Process Improvement: Contribute to the development and implementation of quality improvement initiatives.
Incident Reporting: Report lab incidents, out-of-specification results, and other deviations.
SOP Compliance: Prepare and follow approved departmental SOPs.
Qualifications:
Bachelor's degree in Chemistry, Pharmacy, or a related field.
Relevant experience in a pharmaceutical QC environment.
Knowledge of GMP, FDA, and other relevant regulations.
Strong analytical and problem-solving skills.
Proficiency in QC software and tools.