Cipla Ltd Chemistry/Pharma Job Vacancy – Apply Online
Dont forget to check out possible interview questions for this job below
Cipla Ltd announces M Pharma job opening 2023, M Pharma API ADL Analyst job opening 2023. job opening 2022. B Pharma API ADL Analyst job opening 2023, Cipla ltd job opening 2023, Chemistry job opening 2022. Intrested and eligible candidates may check out all the details
Job Title: API ADL Analyst (44230)
Division IPD
Department IPD
Employment Type Permanent
Job Location Bangalore
Education Qualification
M.Sc. Chemistry /M Pharma / PGD
Relevant Work Experience
Minimum 5 years of experience in pharmaceutical industry with analytical experience
Job Purpose
Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements
Accountabilities
I. Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission
II. Investigate plant queries like OOS, OOT for quality control of drug substance and products in order to provide corrective actions and check samples
for impuritiesIII. Characterise final API and impurities to prepare the test or working standards for routine laboratory purpose
IV. Conduct the incubation and perform complete analysis of stability samples to conclude the storage, shelf life and packing conditions of the final API
V. Keep track of the latest innovation and applications which can be used with the existing techniques to investigate / resolve critical issues
Apply Online
Important Interview Questions and Answers for the above job role:
- What experience do you have in the pharmaceutical industry and how has it prepared you for this role as an API ADL Analyst at Cipla?
Answer: I have over five years of experience in the pharmaceutical industry with a strong background in analytical chemistry. My experience has prepared me well for this role at Cipla because I have extensive knowledge of analytical methods and techniques used in pharmaceutical development, including method development, validation, and troubleshooting.
2. Can you explain your experience with GLP environment and how you maintain it?
Answer: GLP or Good Laboratory Practices is essential for maintaining the accuracy and integrity of analytical data. I have extensive experience working in a GLP environment and ensuring that all laboratory practices are strictly followed, including sample preparation, documentation, equipment calibration, and record keeping. I understand the importance of maintaining a clean and organized workspace to maintain GLP and comply with regulatory standards.
3. How do you approach method development and validation for raw materials, intermediates, and final APIs?
Answer: My approach to method development and validation is systematic and detail-oriented. I always begin with a thorough literature search to identify the most appropriate methods for the specific product and process. I then develop and optimize the method using statistical tools such as DOE and establish the robustness and repeatability of the method. I ensure that the method is validated according to regulatory guidelines before it is used for routine analysis.
4. How do you troubleshoot issues related to impurities in APIs?
Answer: Troubleshooting impurities in APIs requires a methodical approach and a deep understanding of analytical techniques. I begin by identifying the source of the impurity, which could be a raw material, intermediate, or a reaction byproduct. I then investigate the root cause of the impurity by analyzing different samples using various techniques such as HPLC, GC, and MS. Once the impurity is identified, I develop a plan to remove or reduce it in the API using techniques such as crystallization, filtration, or chromatography.
5. What are some of the innovative techniques or applications that you have implemented in your analytical work in the past?
Answer: In my work, I always strive to stay current with the latest innovations and techniques in analytical chemistry. One such technique that I have implemented in the past is UPLC, which provides better resolution, sensitivity, and speed compared to traditional HPLC methods. I have also worked with automation tools such as liquid handling robots and integrated software systems to improve the efficiency and accuracy of data processing and analysis.
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