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    Research Associate I - R&D, F&D

    Baxter
    2+ years
    Not Disclosed
    Ahmedabad
    10 Nov. 15, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Baxter: Where Purpose Meets Innovation in Healthcare

    At Baxter, we are united by a mission that goes beyond business—it’s about saving and sustaining lives. Every role at Baxter contributes to a cause that positively impacts millions of people around the world. Whether you're designing, developing, or supporting medical innovations, your work is crucial in improving patient outcomes globally.

    For over 85 years, Baxter has been a leader in healthcare innovation, pioneering significant advancements that have transformed healthcare delivery. Our products and therapies are used in hospitals, clinics, and homes across the globe, helping save lives and improve patient well-being.

    We foster a culture where employees feel a sense of purpose, are inspired by their work, and succeed together. This is where you can do your best work—at the intersection of saving lives and advancing healthcare.

    Join Our Mission
    At Baxter, we create an environment where your contributions matter, and your work accelerates our mission of improving lives worldwide.

    Key Responsibilities:

    • Communication & Documentation:

      • Good communication skills are required.
      • Take development trials in line with Quality by Design (QBD) principles.
      • Author technical documents like Master Formula Record (MFR), Product Development Reports (PDR), and Product Development Lifecycle Management (PDLM) documents.

    • Cross-functional Coordination:

      • Collaborate with teams including Analytical, Regulatory, PSM, Product Quality, Manufacturing, and Contract Manufacturing Organizations (CMO).
      • Provide project-related information for on-time project delivery in meetings with CMO, Contract Research Organizations (CRO), and contract labs.

    • Stability & Process Support:

      • Coordinate and support the execution of stability batches at Baxter sites and CMOs.
      • Support process validation and commercial batch production.
      • Lead the technology transfer of drug products to Baxter manufacturing plants and CMO sites.

    • Troubleshooting & Audits:

      • Investigate and troubleshoot issues during exhibit and commercial batches, including Out of Specification (OOS) or Out of Trend (OOT) results.
      • Support external and internal regulatory audits and market complaint-related activities.

    • Regulatory Knowledge & Compliance:

      • Stay updated on regulatory submission requirements and guidelines (e.g., ICH, US-FDA, MHRA, EMEA).
      • Ensure compliance with lab equipment, instruments, documentation, and warehouse regulations.
      • Perform required activities for regulatory submissions, queries, and commitments.

    • Safety & Quality Procedures:

      • Conduct Hazard Identification Risk Assessment (HIRA) and work with EHS practices.
      • Ensure compliance with global quality procedures and document experiments in Electronic Lab Notebook (ELN).

    • Continuous Improvement & Resource Management:

      • Ensure all resources, infrastructure, and instruments are available for development lab functions.
      • Initiate and ensure timely closure of change control activities.
      • Request new equipment or instruments for upcoming projects and continuous lab improvement.

    Reasonable Accommodations
    Baxter is committed to providing reasonable accommodations for individuals with disabilities during the application or interview process. If you require assistance, please let us know.

    Recruitment Fraud Notice
    Be aware of recruitment fraud. Baxter will never ask for personal or financial information during the hiring process. Review our Recruitment Fraud Notice to stay informed.

    Apply Now
    Be part of a global leader committed to saving and sustaining lives through innovation and purpose-driven work.

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