Job Description
Perform chemical analysis of APIs, intermediates, and raw materials as per approved specifications and SOPs.
Handle and review analytical testing using HPLC, GC, UV, FTIR, KF, pH, and other QC instruments.
Ensure accurate documentation, data integrity, and timely completion of testing and reporting.
Review analytical results, calculations, chromatograms, and laboratory records.
Support investigation of OOS, OOT, deviations, and laboratory incidents.
Ensure compliance with GMP, GLP, SOPs, and data integrity requirements.
Maintain laboratory instruments, logbooks, standards, reagents, and other QC records.
Participate in method validation/verification, method transfer, and stability studies.
Coordinate with Production, QA, R&D, and other departments for quality-related activities.
Ensure laboratory housekeeping, safety, and compliance with established procedures.
Key Skills
Strong knowledge of API pharmaceutical QC analysis.
Hands-on experience with HPLC/GC and other analytical instruments.
Good understanding of GMP, GLP, OOS/OOT, deviations, and data integrity (ALCOA+).
Strong documentation, analytical, and problem-solving skills.
Ability to independently handle routine QC activities and support investigations.
Good communication and team-handling skills.
Education
M.Sc. Chemistry / B.Sc. Chemistry or equivalent qualification, preferably with relevant pharmaceutical/API QC experience.
