HPLC ANALYST @ INDUS PHARMA INDIA
Indus Pharma India is urgently seeking an experienced and dedicated HPLC Analyst to join our Quality Control team. This is an excellent career opportunity for seasoned pharmaceutical professionals with 3 to 8 years of hands-on experience. The primary focus of this role involves rigorous testing and analysis using High-Performance Liquid Chromatography (HPLC) to ensure product quality and regulatory compliance across various stages of production. The successful candidate will be instrumental in maintaining the highest standards of analytical testing and documentation within our laboratory facility in India.
Key responsibilities include performing accurate HPLC analysis strictly according to approved Standard Test Procedures (STPs) and specifications, covering testing of Raw Materials, Packaging Materials, In-process samples, and Finished Products. The analyst must also be proficient in the preparation and standardization of necessary solutions, and the routine calibration and maintenance of HPLC and other critical QC instruments. Furthermore, a commitment to maintaining comprehensive GMP/GLP documentation, handling Out-of-Specification (OOS), Out-of-Trend (OOT) results, and managing deviations is essential. The role also requires participation in stability analysis and subsequent detailed reporting, all while ensuring strict adherence to current Good Manufacturing Practice (cGMP) guidelines.
Key responsibilities include performing accurate HPLC analysis strictly according to approved Standard Test Procedures (STPs) and specifications, covering testing of Raw Materials, Packaging Materials, In-process samples, and Finished Products. The analyst must also be proficient in the preparation and standardization of necessary solutions, and the routine calibration and maintenance of HPLC and other critical QC instruments. Furthermore, a commitment to maintaining comprehensive GMP/GLP documentation, handling Out-of-Specification (OOS), Out-of-Trend (OOT) results, and managing deviations is essential. The role also requires participation in stability analysis and subsequent detailed reporting, all while ensuring strict adherence to current Good Manufacturing Practice (cGMP) guidelines.
Key Requirements
Perform HPLC analysis as per approved STPs and specifications.
Execute testing of Raw Materials (RM), Packaging Materials (PM), In-process, and Finished products.
Manage the preparation and standardization of solutions required for analytical processes.
Conduct calibration and maintenance of HPLC and other Quality Control (QC) instruments.
Maintain thorough GMP/GLP documentation records.
Efficiently handle Out of Specification (OOS), Out of Trend (OOT), and deviations.
Conduct comprehensive stability analysis and ensure timely reporting.
Ensure complete compliance with cGMP guidelines and regulatory standards.
Possess strong analytical skills for complex problem-solving.
Require 3 to 8 years of hands-on experience in HPLC analysis within a pharmaceutical environment.