Job Summary:
To perform chemical and instrumental analysis of pharmaceutical raw materials, in-process materials, finished products, packaging materials and stability samples as per approved specifications, SOPs, pharmacopoeial methods and cGMP/GLP requirements.
Roles & Responsibilities
Perform sampling and testing of raw materials, APIs, in-process and finished products.
Conduct physical and chemical tests such as assay, identification, pH, dissolution, related substances, LOD/moisture, viscosity, specific gravity and titration, as applicable.
Operate QC instruments such as HPLC, GC, UV-Visible, FTIR, Karl Fischer, Dissolution Apparatus, pH meter and Auto Titrator.
Prepare standard solutions, reagents, mobile phases and test solutions.
Perform stability sample analysis and maintain stability records.
Record test results accurately in worksheets, logbooks and laboratory records.
Prepare/review COA, analytical reports and test documentation.
Follow GMP, GLP, GDP, SOPs and data-integrity requirements.
Report and assist in investigation of OOS/OOT, deviations and laboratory incidents.
Perform routine instrument checks, calibration and maintenance.
Support method validation, method verification, cleaning validation and process validation activities where required.
Coordinate with QA, Production, R&D and other departments for quality-related activities.
Maintain QC laboratory housekeeping and chemical/laboratory safety.
Support internal, customer and regulatory audits.
Required Skills
Pharmaceutical Quality Control testing
Knowledge of GMP, GLP, GDP and SOPs
Hands-on knowledge of HPLC / GC / UV / FTIR
Knowledge of wet chemistry and analytical techniques
Knowledge of pharmacopoeial standards – IP, BP, USP
OOS/OOT investigation knowledge
Good documentation and data-integrity practices
Knowledge of stability testing
Instrument calibration and troubleshooting
Analytical and problem-solving skills
Good attention to detail
Good communication and teamwork
Basic MS Excel and MS Word
Knowledge of laboratory safety and chemical handling
Qualificatio: B.Sc. Chemistry/M.Sc. Chemistry / Analytical Chemistry/B.Pharm / M.Pharm
Experience: 2–5 years in pharma industry