Research Associate I, R&D - F&D

Job Description

Research Associate I, R&D - F&DApply 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.

• 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 CFTs (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 CCNs/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 CMOs for successful technology transfer
• Ensuring Lab equipment, instruments, documentation & Warehouse compliance
• Preparation of SOPs
• Documenting experiments in ELN.
• Identification & request of New Equipments/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.

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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter 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 .052681Apply Now Save Job,

Keyskills :
new product introductionvalidationcalibrationresearchdocumentationhplccontinuous improvement facilitationcorrective preventive actioncorrective preventive action capa