Baxter looking for Senior Research Assistant in R&D - F&D
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.
Post : Sr. Research Assistant, R&D - F&D
• Execution of development trials
• Compilation & evaluation of the development & stability data
• Ensuring 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 Regulatory commitments/OOS/Project CCN'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 response
• Self-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 transfer
• Ensuring Lab equipment, instruments, documentation & Warehouse compliance
• Preparation of SOP's
• Documenting experiments in ELN.
• Identification & request of New Equipment's/Instruments for 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.
Location : Ahmedabad, GJ IN
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D - F&D
End Date : 20th December, 2019
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