The QC-HPLC Executive is responsible for performing analysis of raw materials, in-process samples, finished products, and stability samples using HPLC and other analytical instruments in compliance with GMP and regulatory requirements. The role is critical in ensuring the quality, safety, and efficacy of small volume injectable products. The position involves handling, calibration, and routine operation of HPLC systems, along with accurate documentation and data integrity practices.
Responsibilities
- Operation and maintenance of HPLC systems for routine analysis.
- Analysis of raw materials, finished products, and stability samples.
- Preparation of mobile phase, standard solutions, and test samples.
- Execution of analytical methods as per pharmacopeia (IP, USP, BP) and in-house specifications.
- Documentation of analytical data in compliance with GMP and ALCOA+ principles.
- Calibration and system suitability testing of HPLC instruments.
- Identification and reporting of OOS (Out of Specification), OOT (Out of Trend), and deviations.
- Troubleshooting of HPLC instruments and analytical methods.
- Ensuring cleanliness and proper maintenance of the laboratory area.
- Coordination with QA and other departments during audits and inspections.
Required Skills
- HPLC operation
- Analytical testing
- GMP compliance
- GLP knowledge
- Data integrity (ALCOA+)
- Method execution
- Instrument calibration
- OOS/OOT handling
- Documentation skills
Job Details
- Department: Quality Control
- Job Type: Full time
- Experience: 1-3 years
- Location: Neemrana
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