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.
Post : Research Assoc I, R&D - F&D
Job Description
• To conduct development trials as per requirement.
• To compile & evaluate the development & stability data.
• To ensure development trials to be performed as per Quality By Design (QBD) approach.
• To prepare the technical documents e.g. Master Formula Record (MFR), Product Development Report (PDR), Product Development Lifecycle Management (PDLM) documents, Protocols & Reports.
• To provide required information for meetings with cross functional teams like Analytical, Regulatory, PSM, Product Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management for on time project delivery.
• To provide required information for meetings with Contract Manufacturing Organizations (CMO), Contract Research Organizations (CRO) & contract Labs for on time project delivery.
• To provide support for successful technology transfer of drug products at Baxter manufacturing plant & Contract Manufacturing Sites.
• To review engineering batch & stability batch documents.
• To collect the Stability batch data and review for trending.
• To support for Process validation and commercial batches.
• To perform the required activities for remediation projects to fulfill the regulatory commitments for Out of Specification or Project Change Control Notes or Corrective and Preventive Action or product nature and criticality.
• To perform the required activities to fulfil the regulatory submission & query requirements.
• To prepare the reports to be provided for regulatory response.
• 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 for product Launch.
• To support External and Internal regulatory audits.
• To support for market complaint related activities.
• To be updated on product submission knowledge in regulatory market, current guidelines i.e. ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), US-FDA (United States Food and Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency), EMEA (European Medicines Agency) 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 Initiate change control and ensure timely closure of the same.
• To ensure compliance related to Lab equipment, instruments, documentation & warehouse.
• To document experiments in Electronic Lab Notebook (ELN).
• To identify & request for New Equipment's or 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 Hazard Identification Risk Assessment (HIRA) in coordinates with EHS (Environmental health and safety) practices at place.
• To Document and review the entries in logbooks.
Candidate Profile
M.Pharma in Pharmaceutics
Additional Information
Qual. - M.Pharm
Location : Ahmedabad
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th March, 2023
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