Conduct routine and non-routine chemical and physical analyses of raw materials, in-process samples, and finished products using techniques such as HPLC, GC, UV-Vis, FTIR, and titration.
Perform stability testing and support method development and validation activities.
Document and interpret results, ensuring accurate and timely reporting.
Ensure all testing procedures comply with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and other relevant regulatory standards.
Maintain and calibrate laboratory equipment and instrumentation.
Participate in internal and external audits and implement corrective actions as needed.
Accurately record, analyze, and report test results using laboratory information management systems (LIMS).
Maintain detailed and organized laboratory notebooks and documentation.
Prepare and review standard operating procedures (SOPs), test methods, and validation protocols.
Work closely with production, research and development, and quality assurance teams to address quality-related issues.
Communicate effectively with management and other departments regarding test results, deviations, and corrective actions.
Adhere to all safety and environmental regulations, ensuring a safe working environment.
Participate in safety training and contribute to the development of safety protocols.
Report any safety hazards, incidents, or non-compliance issues promptly.
Qualifications:
Bachelor's degree in Chemistry, Biochemistry, or a related field. Advanced degrees (M.Sc., Ph.D.) are a plus.
Minimum of 2-5 years of experience in a quality control laboratory, preferably within the pharmaceutical, biotechnology, or chemical industry.
Proficiency in analytical techniques and instrumentation (e.g., HPLC, GC, UV-Vis, FTIR).
Strong knowledge of GLP, GMP, and regulatory guidelines (FDA, ICH).
