🏷️ Position Title:
Sr. Associate – QA Compliance
Req #: JR - 173923
Location: Ahmedabad, Gujarat, India
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🧭 Position Overview
At Baxter, this role in Quality Assurance Compliance plays a critical part in safeguarding patient safety by ensuring cGMP compliance, audit readiness, and regulatory adherence across the facility. This role helps maintain the quality systems that support our mission of saving and sustaining lives.
🎯 Key Responsibilities
Conduct internal quality audits to evaluate adherence to systems, SOPs, and compliance with regulatory standards.
Ensure the facility and systems comply with current Good Manufacturing Practices (cGMP) and other regulatory requirements.
Maintain a state of readiness for inspections by regulatory authorities and partners at all times.
Verify that processes are in compliance with SOPs and current regulatory expectations.
Monitor the effectiveness of CAPA related to audit observations and ensure timely implementation.
Participate in and support external audits.
Conduct GEMBA rounds (real-time walkthroughs) across the site to detect and report non-conformities.
Perform periodic assessments of GMP trends and site compliance status.
Contribute to the regulatory intelligence program and assess global observation data for compliance improvement.
Ensure all required initial and ongoing training for personnel is completed and updated per regulatory and operational needs.
Deliver training on evolving regulatory guidelines, quality systems, and process improvements.
Manage and approve changes, procedures, and documentation via electronic Quality Management Systems (eQMS).
Perform data integrity checks and ensure systems are under control, in compliance with ALCOA+ principles.
👤 Success Profile: Key Traits
Baxter values team members who are:
Detail-Oriented
Continuous Learners
Courageous
Collaborative
Critical Thinkers
Influential
📍 Work Location
Manufacturing Facility – Ahmedabad
Sarkhej - Bavia Road
Chacharvadi Vasna
Ahmedabad – 382213
Gujarat, India
🌱 Employee Benefits
Support for Parents
Continuing Education & Professional Development
Health & Well-Being Benefits
Paid Time Off
2 Volunteer Days per Year
⚖️ Equal Employment Opportunity
Baxter is an equal opportunity employer and evaluates applicants regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity/expression, disability, or veteran status.
♿ Reasonable Accommodations
If you need accommodations due to a disability during any stage of the hiring process, click here to request assistance.
⚠️ Recruitment Fraud Alert
Baxter does not request financial or personal information during the recruitment process. Learn more about how to protect yourself from recruitment scams by reviewing our Recruitment Fraud Notice.
📩 Ready to Apply?
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