Research Associate I, Cce - Ahmedabad, India - BAXTER

BAXTER

Verified Company

Ahmedabad, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

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.

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.

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.

Serving as primary packaging expert on technical development teams to provide the bestinclass containers and drug delivery devices for Baxter Pharmaceuticals products
Author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation
Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure drug containers and devices maintain the required level of performance throughout the life of the product
Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOP, protocols, and reports with minimum supervision.
Develop process descriptions to standardize testing procedures. Specify test requirements and acceptance criteria to satisfy quality and regulatory needs (e.g. Design Verification DV, Process Validation PV).
Perform test method qualification and method transfer to GMP testing group in support of device verification & validation testing for prefilled syringes, pen injector and autoinjectors (ISO 11040, ISO 11608)
Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g.
USP/PharmEur, ISO /MDD/GMP/GLP, 21CRF 820.30, ISO 14971 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards.
Establish and foster a strong collaborative working relationship with internal departments and external vendors/suppliers.

Reasonable Accommodations

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