Posted By
Posted in
SCM & Operations
Job Code
1354692
1. Sound Practical Knowledge of HPLC/UPLC method development, method validation for Assay and Related substance of complex injectable, Characterisation including Physical and chemical properties of products like Microsphere and Liposomes injections.
2. Sound practical knowledge of dissolution of USP- type IV instruments method development and method validation for complex injection and evaluation of the analytical data.
3. Sound knowledge of analytical instruments Infrared spectrophotometer, UV spectrophotometer, Auto titrator, Karl Fisher, Viscometer, Rheometer with analytical data interpretation, Gel permeation chromatography (GPC) for molecular weight determination, Scanning electron microscope (SEM), Transmission electron microscope, Differential scanning electron microscopes (DSC) & TGA for characterisation of physical properties.
4. Knowledge of UPLC method development and conversion of analytical method from HPLC to UPLC.
5. Good knowledge and practical hand of reverse engineering to find out the identification and quantification of chemical composition of innovator samples (Q1&Q2)
6. Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.
7. Assists QC and Quality Assurance in investigations of different issues and recommends solutions.
8. Provides timely response to requests for support of manufacturing deviations, investigations and change requests.
9. Ensures that all executed and documented activities are aligned as per company policies and objectives.
10. Good hand of experience of to perform the drug excipient compatibility study and evaluation of analytical data to give the conclusive information to Formulation and developments team.
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Posted By
Posted in
SCM & Operations
Job Code
1354692