Research Associate I, R&D - ADL

Baxter

2 - 5 years

4 - 8 Lacs

ahmedabad

Posted:3 hours ago| Platform:

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Skills Required

operational excellence analytical process improvement risk assessment data collection healthcare research associate hplc preventive maintenance recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

To complete the planned work (Method validation/Submission Studies/Regulatory query) in stipulated time frame given by sub-department manager.
To perform all the testing and data recording of API samples, Development Product samples, Validation Samples, Stability samples, Bulk hold samples, RLD samples, PDR samples etc. according to draft/approved Method of analysis or current Pharmacopoeia.
To operate the different instruments like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter etc. as per approved standard operating procedures.
To calibrate the Instruments as and when required (Daily/as per schedule) like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter etc. as per approved standard operating procedures.
To use live reference standards, working standards and Impurity Standards for analysis and maintain their records.
To verify the shelf life of chemicals and reagents before performing analysis of material or product.
To follow good documentation and ALCOA++ practices.
To follow the good Laboratory practices in the Department.
To follow the instruction and procedure as mentioned in the approved protocol.
To keep track of routine requirements. Inform and ensure timely procurements of the same to respective person or Department.
To Report and investigate any failure / abnormal observation / deviation / Non-Compliance to sub-department manager and seeking for the solutions.
To communicate project related issues to sub-department manager and follow the action plans.
To check the trend of results before reporting the results.
To keep the status of daily work and report to sub-department manager on daily basis.
To prepare standard operating procedures (SOPs) and standard formats for Documentation.
To verify the instruments after maintenance of the Instruments.
To check preventive maintenance, Breakdown Maintenance and perform risk assessment. To report preventive maintenance and Breakdown Maintenance to sub-department manager.
To represent subject matter expertise in the areas of analysis internally and externally as needed.
To make Analytical problem-solving efforts to meet urgent business needs.
To focus on innovation, process improvement, and/or operational excellence.
To execute and manage projects/programs utilize established methods, techniques, or approaches.
To Implement new or improved techniques and procedures around specific tasks; write and implement SOPs.
To complete the training as per the quality matrix targets.
To Maintain knowledge of relevant regulatory requirements related to R&D to ensure compliance in all research, data collection and reporting activities.
In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance.

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