Perform routine chemical analyses using HPLC, GC, UV-Vis, FTIR, titration, and other analytical techniques.
Conduct stability testing and method validations according to ICH guidelines.
Prepare and standardize laboratory reagents and solutions.
Accurately document test results in accordance with cGMP requirements and Good Documentation Practices (GDP).
Review and interpret analytical data, identifying trends or deviations.
Maintain, calibrate, and troubleshoot laboratory equipment as needed.
Participate in investigations related to out-of-specification (OOS) or out-of-trend (OOT) results.
Assist in the development and revision of SOPs, test methods, and validation protocols.
Ensure compliance with all applicable regulatory and safety standards (FDA, USP, ICH, etc.).
Collaborate with other departments such as R&D, Manufacturing, and Quality Assurance to support product release and continuous improvement initiatives.
Qualifications:
Bachelor’s or Master’s degree in Chemistry, Biochemistry, or a related field.
2–3 years of relevant experience in a QC laboratory within the pharmaceutical industry.
Hands-on experience with analytical instruments (e.g., HPLC, GC, UV-Vis, FTIR).
Knowledge of USP/NF monographs and pharmaceutical regulatory guidelines (FDA, cGMP, ICH).
Strong analytical thinking, problem-solving skills, and attention to detail.
Excellent organizational and time-management abilities.
Proficient in Microsoft Office and Laboratory Information Management Systems (LIMS) is a plus.
