Senior Quality Engineer
Location: Ahmedabad, Gujarat, India
Company: Baxter
Job Requisition ID: JR - 193043
Employment Type: Full-Time
Experience Required: 5–8 Years
Job Overview
Baxter is seeking an experienced Senior Quality Engineer to join its Quality and Validation team in Ahmedabad. This role plays a critical part in ensuring compliance with regulatory requirements, validation standards, and global quality systems across equipment, utilities, processes, and facilities.
The selected candidate will lead and oversee validation and qualification activities, manage quality system documentation, and ensure adherence to GMP, regulatory expectations, and Baxter Global Quality Requirements (GQRs). This position is ideal for validation and quality engineering professionals with strong expertise in pharmaceutical manufacturing and regulatory compliance.
Key Responsibilities
Validation and Qualification Oversight
Review executed protocols for equipment validation, process validation, cleaning validation, utility qualification, and HVAC/facility qualification.
Coordinate cross-functionally for planning and execution of validation activities and escalate non-conformities to Head of Department (HOD).
Review and approve scheduled validation activities as per monthly validation calendar.
Ensure proper implementation of validation and qualification activities as per approved procedures.
Update, review, and approve Validation Master Plan in line with site validation policy and regulatory requirements.
Quality Management System (QMS) Compliance
Track and review Change Control Management (CCM), Corrective and Preventive Actions (CAPA), OOS, and Non-Conformance records related to validation activities.
Ensure timely closure of DCRs, CCM tasks, and investigation reports.
Participate in Change Control pre-assessment meetings and perform impact assessments in Trackwise.
Ensure SOPs and protocols align with regulatory guidelines and Baxter Global Quality Procedures (GQPs).
Regulatory and Audit Support
Review summary reports for International Regulatory Affairs (IRA) submissions and ANDA queries.
Participate in internal and external audits and prepare audit responses.
Ensure compliance with validation and qualification expectations as per global regulatory authorities.
Project and Equipment Lifecycle Management
Coordinate with project and engineering teams for new equipment installation and qualification.
Review and approve new equipment qualification protocols in TcU and ensure HOD approval.
Inform Production and Planning teams in advance for validation and qualification activities.
Data Integrity and Documentation
Ensure contemporaneous data recording and proper documentation during validation execution.
Review and approve validation reports and related operational documents.
Maintain periodic qualification calendars and ensure HOD approval.
Leadership and Operational Excellence
Guide and coach team members in protocol development, execution planning, and validation report preparation.
Prepare shift schedules to meet validation activity requirements.
Escalate issues arising during second or night shift validation activities.
Support departmental budget preparation and monitor expenses within allocated limits.
Promote workplace safety and report hazards or near-miss incidents in the safety portal.
Educational Qualification
Bachelor’s or Master’s degree in Pharmacy, Engineering, Life Sciences, or related discipline.
Required Skills and Experience
5–8 years of experience in Validation, Quality Engineering, or Quality Assurance within pharmaceutical or medical device manufacturing.
Strong knowledge of GMP, validation lifecycle (IQ/OQ/PQ), cleaning validation, HVAC qualification, and process validation.
Experience in QMS tools such as Trackwise and document control systems.
Familiarity with regulatory submissions, ANDA documentation, and audit handling.
Excellent cross-functional coordination, analytical, and leadership skills.
Core Competencies
Detail-oriented and compliance-driven
Strong critical thinking and risk assessment capability
Effective cross-functional collaborator
Strong documentation and regulatory knowledge
Leadership and team mentoring ability
Why Join Baxter?
Baxter’s Quality function is integral to its mission of saving and sustaining lives. Employees benefit from a collaborative culture, professional development opportunities, employee well-being programs, paid time off, and structured career growth within a global healthcare organization.
Equal Employment Opportunity
Baxter is an equal opportunity employer and evaluates all qualified applicants without regard to legally protected characteristics. Reasonable accommodations are available for qualified individuals with disabilities during the recruitment process.
This Senior Quality Engineer position is an excellent opportunity for validation and quality professionals seeking advancement in pharmaceutical manufacturing compliance, regulatory readiness, and global quality systems leadership.
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