🏷️ Position Title:
Sr. Specialist, Quality ECM
Req #: JR - 171758
Location: Ahmedabad, Gujarat, India
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🧭 Position Overview
This role is part of Baxter’s Global Quality team, supporting External Contract Manufacturers (ECMs) to ensure compliance with Baxter’s quality standards and global regulatory requirements. You will lead quality activities associated with technical transfers, audits, compliance, CAPAs, and more—making a direct impact on patient safety and product quality.
🎯 Key Responsibilities
🔗 ECM Management
Act as the primary Quality contact for assigned ECM partnerships.
Support onboarding of new ECMs to meet Baxter’s quality expectations.
Assist in the development and maintenance of Quality Agreements with ECMs.
Execute technical transfer activities with Product Quality and Design Quality teams.
🧪 Quality Assurance & Compliance
Ensure ECMs maintain a constant state of inspection readiness.
Participate in regulatory inspections and Baxter audits at ECM sites.
Conduct risk assessments, define mitigation actions, and monitor CAPA implementation.
Review and approve Annual Product Quality Review (APQR) reports for Baxter products at ECMs.
📊 Performance Monitoring
Define and track quality performance metrics for ECMs.
Report deviations, complaints, change controls, and ensure timely resolution.
Perform batch release responsibilities for products manufactured at ECMs.
🚨 Escalation & Issue Resolution
Escalate and manage ECM-related quality issues under the Field Action process.
Handle ECM Supplier Notice of Change (SNC) and assess potential product impact.
Execute Supplier Corrective Action Requests (SCARs) and manage quality notifications from ECMs.
Identify when escalation to SCARs/NCRs is necessary.
🔄 System & Process Improvement
Improve/develop Quality Management Systems (QMS) at selected ECMs.
Support SCAR closure, supplier compliance improvements, and regulatory readiness.
Collaborate with Supply Chain, Regulatory Affairs, Purchasing, and Quality Assurance teams across global Baxter sites.
📌 Qualifications & Competencies
🎓 Education & Experience
Bachelor’s degree in Science, Engineering, or related discipline.
Relevant experience in Quality Assurance, Compliance, or Contract Manufacturing environments (preferred in pharmaceutical or medical device industry).
💡 Skills & Attributes
Strong knowledge of QMS, GMP, and global regulatory standards.
Experience with technical transfer, risk management, and batch release.
Effective communicator with cross-functional and cross-cultural collaboration skills.
Strong attention to detail, critical thinking, and problem-solving skills.
Experience handling audits, CAPAs, complaints, and change controls.
🧬 Ideal Candidate Traits (Success Profile)
Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential
🌱 Benefits
Support for Parents
Continuing Education & Professional Development
Employee Health & Well-being Benefits
Paid Time Off
2 Days Annually for Volunteering
📍 Work Location
Baxter India – Ahmedabad Office
Navratna Corporate Park
Tower A, Ground Floor
Tower B, 21st & 22nd Floor
Ahmedabad – 380058
Gujarat, India
⚖️ Equal Employment Opportunity
Baxter is an equal opportunity employer. Applicants are evaluated without discrimination based on race, gender, religion, age, disability, or other protected characteristics.
♿ Reasonable Accommodations
Baxter is committed to providing reasonable accommodations for individuals with disabilities. For requests during the application or interview process, click here to share your needs and contact details.
⚠️ Recruitment Fraud Alert
Baxter has discovered employment scams involving impersonation of Baxter recruiters. To stay safe, review Baxter’s official Recruitment Fraud Notice.
📩 Ready to Apply?
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