Job Title: Senior Specialist – Quality Compliance
Req ID: JR-184188
Location: Ahmedabad, Gujarat, India
Department: Quality
Company: Baxter
About Baxter
At Baxter, we believe every person—regardless of background—deserves access to a healthy life. Since our founding in 1931, this belief has guided our purpose of saving and sustaining lives.
Our community is built on courage, trust, and collaboration, empowering each individual to make meaningful contributions. Here, you’ll find purpose, pride, and opportunities for growth—because quality at Baxter touches every stage of the product lifecycle.
Role Overview
The Senior Specialist, Quality Compliance is responsible for ensuring that all operations at the Ahmedabad site comply with Baxter’s quality policies, internal standards, and global regulatory requirements.
This role plays a critical part in audit management, QMS compliance, inspection readiness, and continuous improvement of site quality systems.
Key Responsibilities
Audit and Compliance Management
Manage internal and external audits, ensuring audit readiness and compliance with Baxter policies and regulatory expectations.
Maintain and execute internal audit schedules to evaluate adherence to all quality systems and procedures.
Conduct system and facility reviews to ensure continuous readiness for inspections.
Verify that processes and systems comply with Standard Operating Procedures (SOPs) and current regulatory requirements.
Support the Compliance Head or Site Quality Head during external audits and facilitate audit responses by coordinating with cross-functional departments.
Arrange pre-requisites, audit agendas, and support ongoing inspection requests.
Ensure timely closure of audit commitments and verify their effectiveness.
Quality Management System (QMS) Oversight
Manage QMS elements in TrackWise (e.g., audit commitments, CAPA, non-conformance).
Approve and review Document Change Requests (DCRs), Change Controls (CCMs), and related records through Team Center Unify (TCU) or equivalent systems.
Perform GEMBA walks to verify compliance and oversee mitigation of observations.
Ensure data integrity is maintained across all systems and processes.
Review, approve, or reject QMS elements and actions, ensuring timely closure and CAPA effectiveness.
Regulatory & Continuous Improvement
Ensure cGMP compliance based on current inspection trends and global expectations.
Partner with Regulatory Affairs to provide site-related information and documentation for GMP applications.
Oversee Quality Key Performance Indicators (KPIs) and drive improvement initiatives across cross-functional teams.
Promote regulatory awareness and quality culture throughout the organization.
Support regulatory intelligence, gap assessments, global observation certifications, and quality alerts as needed.
Partner with site leaders to implement consistent and efficient quality practices, ensuring scalability of operations while maintaining compliance.
Key Attributes for Success
Detail-Oriented: Accuracy and precision in compliance activities.
Continuous Learner: Eager to stay updated with evolving quality standards.
Collaborative & Courageous: Works effectively with cross-functional teams.
Critical Thinker & Influential: Identifies gaps, proposes solutions, and drives change.
Employee Benefits
Support for parents and families.
Continuing education and professional development programs.
Comprehensive health and well-being benefits.
Paid time off and volunteer leave (2 days per year).
Equal Employment Opportunity
Baxter is an Equal Opportunity Employer.
Qualified applicants are considered without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity/expression, veteran status, or disability.
Reasonable Accommodations
Baxter provides reasonable accommodations to individuals with disabilities during the application or interview process.
If needed, please contact Baxter through the official link with your request and contact details.
Recruitment Fraud Notice
Be aware of fraudulent job postings or communication claiming to represent Baxter.
For your safety, please review Baxter’s official Recruitment Fraud Notice on the company website.
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