25 Oct
|
Baxter International
|
Ahmedabad
25 Oct
Baxter International
Ahmedabad
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
You will provide scientific and regulatory guidance for stability programs, including shelf-life and storage condition recommendations. Working closely with cross-functional teams, you will ensure compliance with global regulatory requirements and project timelines.
Develop and execute stability study designs for current product development and sustaining product projects.
Provide scientific justification for shelf-life, expiration dating, and storage condition recommendations.
Prepare and support regulatory submissions and responses to health authority inquiries.
Ensure compliance with ICH (International Council for Harmonisation) stability guidelines, cGxP, QSRs, and internal quality requirements.
Collaborate with QA, QC, Regulatory Affairs, Manufacturing, and R&D; teams to support project objectives.
Develop and implement SOPs, scientific procedures, and best practices.
Independently manage multiple stability projects and deliverables within established timelines.
M.Pharm or equivalent degree in Pharmaceutical Sciences or related discipline.
~8+ years of experience in Stability Studies, Pharmaceutical Product Development, or related R&D; functions.
Strong knowledge of stability study design, execution, and data interpretation.
In-depth understanding of ICH Stability Guidelines, cGxP requirements, QSRs, and global regulatory expectations.
Experience supporting expiration dating, shelf-life determination, and storage condition recommendations.
Hands-on experience with LIMS and electronic stability management systems.
Strong analytical and scientific problem-solving skills.
Ability to independently manage complex technical projects.
Excellent technical writing and regulatory documentation skills.
Experience with global regulatory submissions and health authority interactions.
Experience leading operational excellence and continuous improvement initiatives.
Broad understanding of pharmaceutical development, manufacturing, and quality systems.
Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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.
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📌 Research Assistant (Healthcare & Science) (Ahmedabad)
🏢 Baxter International
📍 Ahmedabad