Assoc, Quality - Comp Sys Val

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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

Assoc, Quality - Comp Sys Val

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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.

To prepare, review and verify validation documentation such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and update Validation documentation templated as per requirements.
To prepare, review and verify the Computerised system validation documents such as User requirement specification (URS), Functional Requirement Specification (FRS), Design specification (DS), Configuration Specification (CS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability requirement Matrix (TRM) and Validation summary report (VSR) etc.
To prepare, review and verify Gap analysis related to the Computerised system documents to identify the missing GxP documentation and created them as required by the company policies.
To actively engage in review of check lists, templates, format, test cases and test scripts for simple and better testing, better review of validation documents and easy understanding and assuring compliance of Computerised systems as per current regulatory requirements and industry best practices.
To responsible for generation of validation plan (VP), gap analysis at sites to gather requirements for the configuration of new software’s
To prepare an inventory of the computerised system and creation change control documents related to the software.
To play a major role in QC and manufacturing for computerised system validations
To train users and other team members in carrying out validation activities successfully.
To train the projects team members in Good documentation practices (GDPs) and ensure the completion of applicable standard operating procedure and validation trainings.
To investigate QC computerised systems related non-conformities, recommended corrective actions and review related technical reports.
To initiate and keep track of documents change request (DCR), Change control Management (CCM), Non-Conformity (NCR) and Corrective and preventive actions (CAPA) as per requirements in consultation with Sub-Department Manager.
To review and approve all recommendation points of GAP / risk assessment with respect to EU Annex 11, Gamp5, 21 CFR part 11 and other regulations.
To review and approve of all validation documents based on principle of ALCOA++ for validation docs.

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

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Address

Explore this location Sarkhej - Bavia Road
Chacharvadi Vasna
Ahmedabad- 382213
Gujarat
India Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Assoc, Quality - Comp Sys Val

Overview

Success Profile

Assoc, Quality - Comp Sys Val

Address

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Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

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Join Our Talent Community