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Urgent hiring for Research Assoc I, R&D - ADL

3.00 to 6.00 Years   Ahmedabad   07 Jun, 2022
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    Research Assoc I, R&D - ADLApply Now Save JobThis is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.
    • Responsibility of review of DMF for specifications and analytical method including method validation for all the tests in API, and Excipients
    • Responsible for review from suppliers and implementation of declarations (Residual solvents, Elemental impurity, Nitrosamine Impurity etc.) at Baxter
    • Responsibility of review and assessment of SNCs (Supplier Notification) for APIs, Excipients and Packaging materials and their implementation at Baxter
    • Responsibility of preparation of analytical package (Specification, MoA for API, FP, excipients, and packaging material) in close co-ordination with F&D, RA, PQ, Plant/CMOs and PMT
    • Responsibility of review of analytical package (Specification, MoA for API, FP, excipients, and packaging material) for CMOs
    • Responsible for NCR initiation & investigation, CAPA Action (Assignment and closure), CC (Change Control) initiation and closure, owning task with respect to change in documentation
    • Responsible for compendia changes and their assessment for experiment execution, documentation alignment and communication to RA, PQ, Plant/CMOs for their actions
    • Responsible for review of regulatory query and document update in close co-ordination with CFTs
    • Responsible for preparation, review and approval of various SOPs of ADL
    • Additional responsibility of Shipment activities for the Analytical Method Transfer from ADL R&D to Baxter s and non-Baxter s domestic and overseas manufacturing unit (QC lab) and contract testing laboratories for new and existing products which includes API, FP, other resources (Standards, Column, Impurities, Reagents/Chemicals) in close coordination with Finance, Logistic and PMO team
    Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to hidden_email and let us know the nature of your request along with your contact information.Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .067864Apply Now Save Job,

Keyskills :
continuous improvement facilitationpmomethod transferdmfapi

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