Responsibilities
- Carry out stability studies on pharmaceuticals in line with authorized procedures and scheduled timelines.
- Perform chromatographic testing using HPLC/LC, UPLC‑UV, and GC techniques according to validated methodologies.
- Prepare samples through dilution, extraction, filtration, and precise weighing, ensuring accuracy and traceability.
- Conduct all laboratory testing in alignment with GMP guidelines, standard operating procedures, and regulatory standards.
- Support method development by assessing chromatographic parameters, sample preparation approaches, and detection settings.
- Document all laboratory work in notebooks or electronic systems following ALCOA+ principles for data integrity.
- Evaluate and interpret analytical results, verifying correctness prior to reporting.
- Operate, calibrate, and perform maintenance on analytical equipment such as HPLC/UPLC, GC, UV detectors, and balances.
- Complete routine system suitability tests and troubleshoot instrument issues as needed.
- Collaborate with Quality Assurance and equipment suppliers to maintain instrument qualification status.
