🏷️ Position Title:
Associate, Quality – Qualification & Validation (Q&V)
Req #: JR - 171772
Location: Ahmedabad, Gujarat, India
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🧭 Position Overview
As part of Baxter’s Quality team, this role focuses on equipment, utility, facility, and process validation, ensuring compliance with cGMP, internal quality systems, and regulatory requirements. The Associate, Q&V collaborates cross-functionally to support validation, documentation, and audit-readiness while contributing to Baxter’s mission of saving and sustaining lives.
🔍 Key Responsibilities
🧪 Validation & Qualification Activities
Prepare, execute, compile, and review protocols for:
Equipment qualification
Utility and facility qualification
Process and cleaning validation
Prepare monthly and annual validation calendars and submit for review and approval.
Ensure validation samples are withdrawn and documented during execution.
🤝 Cross-Functional Coordination
Collaborate with various departments for planning and execution of validation activities.
Communicate any non-conformities to the Supervisor during validation execution.
Coordinate with project teams for new equipment installation and qualification planning.
🗃️ Documentation & Compliance
Ensure timely completion, compilation, and review of executed validation protocols.
Maintain accurate and compliant documentation as per regulatory expectations.
Prepare and update Validation Master Plan (VMP) based on guidelines or audit requirements.
Track and close related documents in TrackWise (QMS platform).
⚙️ Quality Management Systems (QMS)
Monitor and handle QMS elements related to validation:
Change Control Management (CCM)
Corrective and Preventive Actions (CAPA)
Non-conformance
Out of Specification (OOS)
Participate in QMS investigations and ensure proper closure.
📤 Regulatory & Audit Readiness
Collect and compile summary reports and data for submission to International Regulatory Affairs (IRA) for ANDA queries.
Assist during internal and external audits, inspections, and regulatory queries.
📚 Training & Continuous Improvement
Attend and complete protocol-specific training prior to validation execution.
Keep protocols and documents updated in alignment with current regulatory requirements.
Suggest and implement document improvements for regulatory compliance.
🚨 Safety & Shift Communication
Be vigilant about safety, report hazards or near misses using the appropriate portal.
Participate in daily meetings to communicate progress or issues from the shift’s validation activities.
🧾 Other Responsibilities
Review and approve validation and operational documents.
Execute any additional responsibilities assigned by the Supervisor.
👤 Success Profile: Key Traits
Baxter is looking for candidates 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 Days a Year to Volunteer
⚖️ Equal Employment Opportunity
Baxter is an equal opportunity employer. All qualified applicants will be considered regardless of race, religion, gender, sexual orientation, disability, or veteran status.
♿ Reasonable Accommodations
If you require accommodations due to a disability during the recruitment process, click here to submit your request and contact details.
⚠️ Recruitment Fraud Notice
Baxter warns of fraudulent recruitment practices. Learn how to protect yourself by reading our Recruitment Fraud Notice.
📩 Ready to Apply?
Click here to Apply Now
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