Analytical Scientist-Oligonucleotide(API) Biocon

3.0 - 7.0 years

0 Lacs

karnataka

On-site

You must have experience in analytical development or handling of oligonucleotides method development. Additionally, you should possess experience in characterization techniques related to oligonucleotides. In this role, you will be responsible for providing routine analysis support to the process development team for various projects. It is essential that you have good documentation skills in line with laboratory GMP practices and the ability to understand and adhere to current Good Manufacturing Practices. Your duties will include ensuring compliance with all quality audits, maintaining data integrity, and following ALCOA++ Principles. You will also be required to prepare and review method development reports, method validation protocols, and reports. Experience in method qualification activities is necessary for this position. As part of your responsibilities, you will work with the instruments assigned for analysis and be involved in their calibration. Collaboration with DQA/Plant QC for method transfer will also be expected. Any additional experience in characterization techniques of oligonucleotides and peptides will be considered advantageous. It is preferable that you have experience in amino acids analysis, SEC-MALS, DLS, CE, and other related techniques. Interpretation of characterization data is a crucial aspect of this role, and you should be capable of performing this task effectively.,

Posted 4 days ago

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Executive/Senior Executive SUN PHARMA

5.0 - 9.0 years

0 Lacs

haryana

On-site

As an Executive/Senior Executive in the R&D Quality-CMC QA department at Sun Pharmaceutical Industries Limited in Gurugram, your primary responsibility will include reviewing various R&D documents such as stability data, analytical reports, method qualification reports, method verification reports, method validation protocols & reports, working standard/impurity standard profile, analytical data of pilot bio batches, and method transfers protocol & report. You will also be required to review lab events, deviations, change control, CAPA, and associated investigation reports before Technology Transfer. Additionally, you will support and participate in failure investigations to resolve root causes for issues related to systems and products developed within the R&D sites. You will visit AD Labs/Areas to ensure compliance with GDP & GMP standards and conduct audits of the Analytical Development department. It will be your responsibility to ensure that periodic activities as per the quality procedures are performed in a timely manner and collaborate with cross-functional and corporate teams for audit readiness. You will lead the assessment, tracking, and monitoring of identified actions as part of various corporate initiatives and support the operations team during corporate and external audits. Furthermore, you will review and approve product development data and specifications, in addition to performing any other duties assigned by the Functional Head. Your role will be critical in maintaining the quality standards and compliance within the R&D Quality-CMC QA department, contributing to the overall success of Sun Pharmaceutical Industries Limited.,

Posted 1 week ago

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