Assoc I, Quality Assurance

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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 I, Quality Assurance

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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.

Job Responsibilities:

To take instructions from supervisor or QA Head to manage Document Control activity.
To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards.
To review and verify that any GDP issues have been addressed.
To issue and close Logbooks to the respective plant, as per request of respective department from Controlled Forms System (CFS).
To archive executed Logbooks, Standard Formats, Batch Manufacturing Record in the record room and submit to central record room.
To issue completed records from record room and ensure its storage, achieve & timely disposition.
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for each new product introduced for manufacturing, whether for regulatory filings (exhibit batches) or for commercial distribution (approved products).
To review BMR based on initial product transfer input received from Quality or F&D / TTD as per requirement.
To Prepare / review BMRs and BPRs by integrating product specifications from Technical Package (TP) and processing parameters from site.
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) in TcU, based on approved BMRs and BPRs production planning schedule and after generating a batch number assignment.
To review departmental Standard Operating Procedure and keep it updated by providing inputs for IPQA functions as per regulatory guidelines.
To maintain Bill of material, Creation of HALB code in JDE.
To review cross-functions Standard Operating Procedure and keep it updated by providing inputs for Document Control functions as per regulatory guidelines.
To prepare annual product review report and submit to IRA for dossier updation
To prepare change control management (CCM) or document change request (DCR) for Document Control.
To raise Non-conformance Report (NCR) and complete investigation report with appropriate correction and/or preventive actions if any non-compliance occurred during execution of Document Control activity.
To perform execution task for Corrective Action and Preventive Action.
To perform execution task for Change Control Management.
To prepared, review or revised SOPs at regular interval to meet regulatory requirement or complies internal audit observation (if any).
To support cross-functional department staff for any Batch records related query resolution.
To generate and review stability intimation slip in ELN.
To seek area of improvement from QA Head and implement action plan.
To communicate any failure or abnormal notification to Supervisor and QA Head for their attention and seeking for the solution.
To communicate any gap or abnormality observed during data verification to Supervisor or QA Head.

Qualification and Experience:

B.Pharma
Exp- 3-7Yrs

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.

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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.

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Assoc I, Quality Assurance

Overview

Success Profile

Assoc I, Quality Assurance

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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