Research Associate III, R&D-F&D
Research Associate III, R&D-F&D
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Job Description
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. 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 liveswhere your purpose accelerates our mission.
Essential Duties and Responsibilities.
Quality:
- To conduct development trials as per requirement.
- To compile & evaluate the development & stability data.
- To ensure development trails 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 support in execution of stability batches in Baxter sites & CMOs.
- To support for Process validation and commercial batches.
- To provide support for successful technology transfer of drug products at manufacturing plant & Contract Manufacturing Sites.
- To review engineering batch & stability batch documents.
- To collect the Stability batch data and review for trending and conduct review of artworks.
- To support subdepartment manager to review the technology transfer documents for products developed by CRO & assess the documents which are inline with QBD based approach & as per current regulatory requirement.
- 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 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 (International Council forHarmonization of Technical Requirements for Pharmaceuticals for Human Use) USFDA (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 carryout the daytoday functions and ensure entire documentation related to formulation development & execution of batch.
- To assist Subdepartment Manager & Department Head in investigation for complaints and deviations. To analyze investigation 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.
- To ensure compliance related to Lab equipment instruments documentation & warehouse.
- To prepare and file change control for updation of SOP and send for further review of Subdepartment Manager & approval of Department Head.
- To document experiments in Electronic Lab Notebook (ELN).
- To identify & request for New Equipments 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.
Administrative:
- To work collaboratively in crossfunctional teams.
- To liaise with customers staff and suppliers for material procurement or query related or any other work.
- To review the entries in logbooks.
- In the absence of Executive Subdepartment Manager will ensure these roles and responsibilities.
Authorities for rejections or approval:
- To hold the projects due to lack of resources as per guidance by Subdepartment Manager.
- To take decision for noncompliance results as per guidance of Subdepartment Manager.
Communication to the management / superiors:
- To communicate with sourcing team if any information requires from suppliers.
- To communicate with cross functional team if any information required for product development.
- To communicate about any failure or abnormal notification or noncompliance results to Subdepartment Manager & Department Head for their attention and seeking for the solution.
- To communicate project related issues to Subdepartment Manager and implement action plan under the guidance of Subdepartment Manager.
Qualifications: Educational Qualification: Masters in pharmacy / Pharmaceutics
- Masters degree with 815 years pharmaceutical experience.
- Writing and computer skills relevant to recording original data as well as creating protocols reports and presentations to communicate with partners and team members.
- The ability to energetically attack a problem and synthesize the results into a clear and logical summary in a timely manner is critical.
- Subject matter expertise in areas associated with modern formulation instrumentation. Ability to learn and master new development strategy and develop new methods where appropriate.
- Communication skills to build relationships across functional and geographical boundaries and present technical concepts to technical and nontechnical teams.
- Comfort with risk and ambiguity ability to negotiate critical timelines for analysis in emergency situations.
- Personal responsibility and independent ownership of analysis and results.
- Experience with leading large projects and formulation development and technology transfer.
- A good understanding of ICH and cGxP practice.
- Experience in working in global crossfunctional teams and project management is a plus.
- Quality oriented.
- Ability to adapt to changes and to work in a team environment as well as delegate effectively to junior team members.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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Required Experience:
IC
Employment Type
Full-Time
