Assoc, QA - Batch Release

Apply Now

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, QA - Batch Release

Apply Now

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. 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. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Batch Disposition post reviewing the batch manufacturing, packing, and testing records assuring compliance with established SOP’s, specifications, and standard formats and ensures that all investigations related to batch are closed prior to the batch disposition.

Assess the impact of proposed changes & recommended changes for batch release function by providing impact assessment to the change proposals.

Identify, investigate, and resolve all discrepancies and non-conformities in the process, systems or documents.

Ensure impacted batches are quarantined until disposition. Put on hold the batches impacted by Quality, out of specification, departure from the established procedures and processes, impacted for the causes related to market complaints.

Conduct investigation within the quality purview to determine the impact, root cause, and the patient safety of a product identified with departure from established system (Specification, process attributes, market surveillance information).

Identification of batches affected with non-conformance of established quality attributes, followed by movement of batches to rejected area and to ensure destruction of the batches per established procedures.

Reconcile the batch and attributed packaging materials with appropriate documentation and traceability. Prepare /submit Certificate of Conformity (CoC) and Certificate of Manufacturing (CoM) as per the requirement of Quality and Business development department.

Verify that Serialization data verification in EMV’s is completed before the COC preparation. Control the on-status batch shipment process of Baxter Ahmedabad, by assuring necessary documents associated with on-status release, compliance to the procedure and to establish communication with warehousing under Baxter’s control to provide necessary decision on batch disposition.

Report batch released/rejected status to Supervisor/Head QA on daily basis by maintaining a tracker. Support PAC/RA team for quality related query/updates to QP and to provide all necessary information/data through documents.

Escalate necessary regulatory/Government related queries, and actions associated with released products and to support the authorities continuously with necessary documentation/updates.

Support all compliance, quality related initiations to ensure site is in continuous state of compliance with respect to the products manufactured and released.

Equal Employment Opportunity

Baxter is an equal opportunity employer. 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.

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.

Apply Now

Address

Explore this location Sarkhej - Bavia Road
Chacharvadi Vasna
Ahmedabad- 382213
Gujarāt
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.

Join Now

Assoc, QA - Batch Release

Overview

Success Profile

Assoc, QA - Batch Release

Address

Share

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

Related Content

Join Our Talent Community