Senior Executive I – Quality Assurance
Location: Ahmedabad, Gujarat, India
Company: Baxter
Job Requisition ID: JR - 194799
Employment Type: Full-Time
Experience Required: 3–6 Years
Job Overview
Baxter is seeking a Senior Executive I – Quality Assurance to join its Ahmedabad manufacturing facility. This role ensures product safety, regulatory compliance, and adherence to Good Manufacturing Practices (GMP) throughout the product lifecycle. The candidate will support batch execution, quality monitoring, and process improvement, directly impacting patient safety and operational excellence.
This position is ideal for professionals with hands-on experience in pharmaceutical or medical device quality assurance, with strong expertise in quality systems, CAPA, data integrity, and regulatory compliance.
Key Responsibilities
Batch Execution & Manufacturing Oversight
Follow instructions from Supervisor and Shift Lead to perform shift activities.
Verify issuance and dispensing of raw materials and primary packaging materials against approved batch records.
Conduct line clearance at various manufacturing and packaging stages as per Batch Manufacturing Records (BMR).
Perform routine in-process checks, sampling, verification, and online documentation. Escalate non-conformances and ensure CAPA implementation.
Collect in-process, finished product, and other samples for timely submission to QC/microbiology.
Data & Systems Management
Review electronic records and audit trails for equipment including autoclaves, sterilizers, and filter integrity machines.
Maintain admin logins for equipment, including activation, deactivation, and periodic access verification.
Initiate batch numbers in BaxLIMS after verifying manufacturing and expiry dates, correcting entries as needed.
Approve preventive maintenance activities in MAXIMO and perform risk assessment review.
Quality Assurance & Compliance
Ensure compliance with Good Documentation Practices (GDP) for logbooks, records, and supporting documents.
Support investigations related to product complaints, non-conformities, and Out of Specification (OOS) results.
Execute CAPA within defined timelines.
Raise and track Document Change Requests (DCR) and Change Control Management (CCM) to closure as per SOPs.
Prepare, review, and update Standard Operating Procedures (SOPs).
Process Monitoring & Data Analysis
Perform stagewise BMR review to ensure batch execution compliance.
Track Continued Process Verification (CPV) programs and prepare Minitab files for products as per production plans.
Collect CPP and CQA data, perform analysis, and report abnormalities to Supervisor/Shift Lead.
Operational Excellence & Communication
Ensure shift-to-shift handover and maintain accurate logbooks.
Communicate failures or abnormal notifications to Supervisor and Shift Lead for timely resolution.
Perform impact assessments for breakdown maintenance and approve activities in MAXIMO.
Coordinate periodic building inspections with Admin team and manage material stock blockage/unblockage.
Support any additional responsibilities assigned by Shift Lead or Reporting Manager.
Educational Qualification
Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related discipline.
Required Skills and Experience
3–6 years of Quality Assurance experience in pharmaceutical or medical device manufacturing.
Strong knowledge of GMP, CAPA, OOS, Change Control, BMR review, LIMS, and MAXIMO systems.
Experience in data analysis, CPV tracking, and ensuring data integrity.
Excellent documentation, analytical, and communication skills.
Key Competencies
Detail-oriented with strong compliance focus
Critical thinker with problem-solving abilities
Collaborative and cross-functional coordination skills
Continuous learner with regulatory awareness
Effective escalation and decision-making skills
Why Join Baxter?
At Baxter, quality is central to our mission of saving and sustaining lives. Employees benefit from:
Continuing education and professional development programs
Health and well-being benefits
Paid time off and volunteer leave
Inclusive and collaborative workplace culture
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 globally.
This Senior Executive I – Quality Assurance role is ideal for professionals seeking growth in pharmaceutical quality systems, regulatory compliance, and manufacturing excellence in a global healthcare organization.
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