Job Title:
Shift Lead I – Quality Assurance
Job Requisition Number: JR-183207
Location: Ahmedabad, Gujarat, India
Company: Baxter International Inc.
About Baxter
At Baxter, we are driven by our mission to Save and Sustain Lives. Since 1931, we’ve worked to redefine healthcare by delivering innovative and reliable medical solutions. Every day, Baxter’s products make a difference in hospitals, clinics, and homes around the world.
As a part of the Quality team, you will directly contribute to ensuring patient safety and product excellence. Quality at Baxter spans the entire product lifecycle and offers vast opportunities for professional growth.
Position Summary
The Shift Lead I – Quality Assurance is responsible for supervising all In-Process Quality Assurance (IPQA) activities during their assigned shift. This includes ensuring regulatory compliance, data integrity, GMP readiness, and coordination with cross-functional teams. The role requires active leadership in issue resolution, documentation review, audit preparedness, and process improvement.
Key Responsibilities
1. IPQA Oversight & GMP Compliance
Supervise all IPQA activities on the shop floor and report updates to QA Head.
Ensure audit readiness and GMP compliance at all times.
Monitor for data integrity across manufacturing operations.
Halt production when necessary, in consultation with QA Head, if GMP violations are observed.
2. Documentation & Review
Review and approve:
Master Formula Records (MFR)
Batch Manufacturing Records (BMR)
Standard Operating Procedures (SOPs)
Qualification protocols and reports
Control Process Validation (CPV) and APQR reports
Risk assessments, facility layouts, engineering drawings
Review/approve executed validation documents, trend reports, and miscellaneous study protocols.
Ensure proper document change control and closure of CFS documents.
3. Audit & Regulatory Support
Address and respond to IPQA-related queries from:
Regulatory agencies
International Regulatory Affairs (IRA)
Business partners
Ensure effective implementation of audit commitments and track their status.
Participate in internal/external audits and support audit trail reviews.
4. Quality Investigations & CAPA
Review and approve:
Out of Specification (OOS)
Out of Trend (OOT)
Non-conformance
Change Controls (CCM)
CAPA reports
Participate in CAPA meetings, ensure timely review of summary reports.
Oversee effective investigations and timely closure of quality issues.
5. Team Supervision & Training
Train IPQA team on current procedures, regulatory guidelines, and new SOPs.
Allocate and monitor team responsibilities.
Conduct daily morning meetings to review activities and escalate concerns as needed.
6. Cross-functional Collaboration
Coordinate with production, planning, engineering, validation, and QA teams.
Review production plans and suggest proactive changes if needed.
Approve product/sample destruction processes and maintain proper logs.
7. Equipment & Process Assurance
Ensure calibration and validation of instruments.
Review and approve instrument calibration failure records.
Review breakdown maintenance reports (Maximo).
Ensure visual inspection qualification is conducted per SOPs.
8. Additional Responsibilities
Ensure GQP assessments and implementations are completed as required.
Verify change parts before batch commencement.
Work as designee of QA Head for allocated lines and assume delegated responsibilities as assigned.
Required Skills & Competencies
Strong knowledge of GMP, GDP, and Quality Management Systems
Excellent skills in documentation, audits, CAPA, and regulatory compliance
Ability to lead cross-functional teams and drive quality improvements
Proficient in analyzing production/process issues and implementing corrective actions
Effective communication and leadership abilities
Baxter's Quality Team Success Traits
Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential
Benefits & Culture at Baxter
Support for Parents
Professional Development & Continuing Education
Paid Time Off
Employee Health & Well-being Programs
2 Days per Year for Volunteering
Equal Employment Opportunity
Baxter is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, veteran status, disability, or any other protected characteristic.
Reasonable Accommodations
Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you require support for any part of the application or interview process, click here to request assistance.
Recruitment Fraud Warning
Beware of fraudulent job offers. Baxter never asks for payment or personal financial information during the recruitment process. Visit our official Recruitment Fraud Notice for more details.
Work Location
Baxter – Manufacturing Facility
Sarkhej - Bavia Road
Chacharvadi Vasna
Ahmedabad – 382213
Gujarat, India
Apply Now
Click here to apply (Insert official link to application portal)
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