GMP Chemist

Job Responsibilities:

• Perform routine and non-routine analytical testing of raw materials, in-process samples, and finished products using various techniques such as HPLC, GC, UV-VIS, and other analytical methods.
• Conduct method development, validation, and troubleshooting of analytical methods as needed.
• Ensure all testing and documentation are performed in compliance with GMP, GLP, and other regulatory requirements.
• Accurately record and maintain data, ensuring thorough documentation in electronic and paper-based laboratory notebooks.
• Prepare and review SOPs, testing protocols, and technical reports.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Research & Development, to resolve technical issues and support product development.
• Assist in laboratory maintenance, including calibration and qualification of analytical instruments, and ensure a clean and safe working environment.
• Participate in investigations and troubleshooting for deviations, out-of-specification results, and other quality-related issues.
• Contribute to continuous improvement initiatives to enhance laboratory efficiency and compliance.

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering or a related field.
• Minimum of 5 years of experience in a GMP environment.
• Proficiency in analytical techniques such as HPLC, GC, and UV-VIS spectroscopy.
• Familiarity with GMP, GLP, and regulatory guidelines (FDA, ICH, etc.).
• Strong attention to detail and organizational skills.
• Excellent communication and teamwork abilities.