Opportunity for M.Pharm, B.Pharm as Research Associate at Baxter

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 : Research Associate III - Stablity (R&D)

Job Description
• Develop stability study designs for new product development and sustaining product projects.
• Make sound technical recommendations regarding stability study designs for new product development and sustaining product projects that are more routine than not.
• Provide some analysis/redesign of key experimental procedures.
• Employ appropriate techniques/methods to successfully and independently complete routine assignments related to stability study design and development within agreed timelines.
• Identify alternative methods and technologies for improving existing or new products/processes.
• Maintain relevant QSRs and other regulatory requirements, such as the stability related ICH guidelines, for R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
• Recommend appropriate study designs, techniques, and processes for a specified sequence of tasks where needed, including the use of LIMS systems for electronic stability protocols.
• Demonstrate ability to apply technical theories and principles to projects for nonroutine tasks. Analyse and figure out the best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications
• Providing technical rationale for expiration dating and label storage statement recommendations, preparing regulatory submissions, responding to regulatory communications.
• Ensuring compliance related deliveries are completed as per plan and decided timelines.
• Independently plan and complete a series of stability study designs and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated timelines.

• Play a lead role in the evaluation, selection and adaptation of various techniques/strategies, which accomplish business objectives such as quality and cycle time.
• Displays a solid understanding of theories/practices applied by other fields outside the primary area of expertise.
• In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, can be able to provide advice and/or is an active participant in the generation, review, adoption, and interpretation of such regulations.
• Maintain focus on meeting both external and internal customer expectations.
• Contribute to technical feasibility analysis of complex research and design concepts.
• Evaluate results relative to product requirements, definitions and/or program goals.
• Ensuring compliance related results are completed on schedule and per plan.
• Collaboration with cross functional teams such as QA, M&Q, Regulatory, Quality control, and all the projects.
• Coordinate with team members to progress the projects and internal activities in a right direction to achieve the organizational requirement.
• Maintain audit readiness and keep lab premises clean & tidy.
• To follow all the relevant cGxP and related regulations.
• Own the analytical problem-solving efforts to meet urgent business needs.
• Focus on innovation, process improvement, and/or operational excellence initiatives.
• Independently plan, execute, and manage projects/programs that both span multiple fields and use established methods, techniques, or approaches.
• Implement new or improved techniques and procedures around specific tasks; write and implement SOP's.
• Expertise to develop new and improved products.
• Able to handle the NCR/sNCR and Change controls.
• Participate and Drive harmonization efforts across Baxter sites for stability practices

Candidate Profile
Educational Qualification- Graduate / Postgraduate in Pharmacy from a reputed institution.
Experience Range (desirable) – 6-12 years of experience in IN-PROCESS and R&D STABILITY analysis.
Proven experience in stability protocol writing and responding to regulatory queries.
Experienced in managing OOS investigations, deviations, change controls & CAPA’s as per GMP procedures.

Additional Information
Experience : 6-12 years
Qualification : Graduate / Postgraduate in Pharmacy
Location : Ahmedabad, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Stablity (R&D)
End Date : 10th July 2024