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Sr. Associate, Technology Transfer

4.00 to 9.00 Years   Ahmedabad   07 Jun, 2022
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Sr. Associate, Technology Transfer
    • To Co-ordinate between R&D team and QC team during the analytical method transfer process
    • To coordinate with R&D team for successful transfer, scale up of product and resolving challenges in commercial products.
    • To review the method transfer protocols and built-up appropriate controls in the Analytical documents to reduce future noncompliance.
    • To investigate any manufacturing process failure/variation, Out of specifications (OOS) and identify the appropriate corrective and preventive actions (CAPA) during exhibit & commercial batch manufacturing & subsequent drive such elements in Trackwise as well
    • To evaluate the method development documents and challenge the method robustness and ruggedness
    • To track, coordinate & supervise for for the R&D batches during exhibit batches execution, stability and regulatory filing
    • To identify the process improvement in the ongoing process and efforts to enhance the process compliance, regulatory compliance, process simplification . Ensure QMS elements i.e. CCM etc closure in track wise
    • To evaluate the impact of changes proposed by vendor/Pharmacopoeial updates in any material/products and work with team for its smooth implementation
    ,

Keyskills :
continuous improvement facilitationmethod transfermethod developmentprocess compliancepreventive actionsprocess improvement

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