Location: Vadodara, Surendranagar
Job Purpose
To perform chemical analysis of raw materials, in-process samples, finished products, stability samples, and other QC samples using HPLC, in accordance with approved specifications, analytical methods, SOPs, and GMP requirements.
Key Responsibilities
- Perform routine analysis of QC samples using HPLC.
- Operate, calibrate, and maintain HPLC instruments as per approved SOPs.
- Perform system suitability tests, standard/sample preparation, and chromatographic analysis.
- Review chromatograms, integration, calculations, and analytical results.
- Handle HPLC-related troubleshooting and coordinate with the concerned team for instrument-related issues.
- Perform analysis as per approved STP/analytical methods and specifications.
- Maintain complete and accurate analytical records, worksheets, logbooks, and instrument usage records.
- Ensure compliance with GMP, GLP, data integrity, and laboratory safety requirements.
- Support method validation, method verification, method transfer, and analytical method development activities as required.
- Handle OOS/OOT investigations and provide analytical support as required.
- Ensure proper handling, storage, and disposal of chemicals and samples.
- Participate in instrument qualification, calibration, and preventive maintenance activities.
- Follow all QC procedures and maintain good housekeeping in the laboratory.
Required Qualification
- B.Sc./M.Sc. in Chemistry, Pharmaceutical Chemistry, Analytical Chemistry, or a related field.
- Diploma/Bachelors degree in Pharmacy may also be considered based on experience.
Experience
- 1–5 years of relevant experience in a pharmaceutical/API QC laboratory.
- Hands-on experience in HPLC analysis is required.
- Experience with instruments such as Shimadzu, Waters, Agilent, or equivalent will be preferred.
Required Skills
- Good knowledge of HPLC operation and troubleshooting.
- Knowledge of GMP, GLP, SOPs, and data integrity.
- Good understanding of analytical calculations and chromatographic interpretation.
- Good documentation and communication skills.
- Ability to work independently as well as in a team.