Research Assoc I, R&D - F&D

Baxter

2 - 5 years

6 - 10 Lacs

ahmedabad

Posted:1 day ago| Platform:

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Skills Required

procurement remediation anda packaging mfr healthcare continuous improvement raw material recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Execution of Project technical feasibility experiments.
Initiate Resource procurement
Execution of developmental trials, PDR studies/QBD additional studies for ANDA injectable products.
Compilation of developmental data
Prepare technical documents e.g. MFR, PDR and other protocols reports.
Coordination with CFTs (ADL, IRA, Procurement, Quality) for on time resource availability.
Successful execution of Exhibit batches at Baxter / CMO sites.
Review of commercial products Raw material, packing material product specifications.
Perform remediation trials and document preparation based on Regulatory commitments/OOS/Project CCNs/CAPA/Product nature and criticality.
Perform trials for regulatory query support Prepare reports to submit for regulatory response .
Perform Lab equipment, instruments, documentation Warehouse document entry as per SOP Prepare and revise SOPs
Identification request of New Equipments/Instruments for projects in upcoming portfolio continuous improvement of Development Lab.
Adoption of GQP (Procedures integration with Baxter systems)
Adoption of TcU ()
Adoption of PDLM (Product development life cycle management)

Education : M- Pharmacy / Ph.D

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