Research Associate II, R&D
4 weeks ago
This is where you save and sustain lives
At 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. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's 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.
Execution of development trialsCompilation & evaluation of the development & stability dataEnsuring development trails to be performed as per QBD approach.Prepare the technical documents e.g. MFR, PDR, PDLM documents, Protocols & Reports.Provide required information for meetings with CFT's (Analytical, Regulatory, PSM, Quality, manufacturing, CMO, Project management) for on time project delivery.Provide required information for meetings with CMO’s CRO’s & contract Labs for on time project delivery.Support for successful Technology transfer of Drug products.Support in execution of stability batches in Baxter sites & CMO.Support for Process validation and commercial batches.Technology transfer documents review of Products developed by CRO as per regulatory requirement.To review engineering batch & stability batch documents.Collection of the Stability batch data and review for trending.Review of Artworks.API, Raw material, packing material & Product specifications preparation & review of developmental products & commercial products. Raw material and packing material specifications for the regulatory filing, CMO & for manufacturing plant.Perform the required activities for remediation projects to fulfill the Regulatorycommitments/OOS/ProjectCCN's/CAPA/Product nature and criticality.Perform the required activities to fulfil the regulatory submission & query requirements.Prepare the reports to be provided for regulatory responseSelf-Knowledge enhancement.To handle trouble shooting during exhibit and commercial batches with an ability to investigate any Out of Specification (OOS) or Out of Trend (OOT) results.To interact with the plant team and impart new product introduction prior to start of production.To support External and Internal regulatory audits with respect to Manufacturing Process.To support for market complaint related activities.To possess and be updated on product submission and knowledge in regulatory market, current guidelines i.e. ICH, US-FDA, MHRA, EMEA etc.To identify & make available the necessary required resources or infrastructure or instruments to carry-out the day-to-day functions. And ensure entire documentation related to formulation development & execution of batch.To assist Manager & Department Head in investigation for complaints and deviations. To analyze investigation done by Executive, to suggest any further actions required, to conclude root cause and to seek approval of Corrective and Preventive Action (CAPA) from Department Head.To prepare change control and ensure timely closure of the same.Support & coordination with CMO's for successful technology transferEnsuring Lab equipment, instruments, documentation & Warehouse compliancePreparation of SOP'sDocumenting experiments in ELN.Identification & request of NewEquipment's/Instrumentsfor projects in upcoming portfolio & continuous improvement of Development Lab.To adopt & follow the Global Quality procedures.To identify the safety hazards & perform the HIRA in coordinates with EHS safety practices at place.-
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