Senior Executive I – Quality Assurance
Location: Ahmedabad, Gujarat, India
Company: Baxter
Job Requisition ID: JR - 191333
Employment Type: Full-Time
Experience Required: 3–6 Years
Job Overview
Baxter is hiring a Senior Executive I – Quality Assurance for its Ahmedabad manufacturing facility. This role is critical in ensuring GMP compliance, data integrity, batch record accuracy, and overall product quality across manufacturing and packaging operations. The position directly contributes to patient safety and regulatory compliance throughout the product lifecycle.
This opportunity is ideal for mid-level Quality Assurance professionals with hands-on experience in pharmaceutical or medical device manufacturing environments.
Key Responsibilities
Manufacturing and Batch Compliance
Perform line clearance activities at various manufacturing and packaging stages as per approved BMR.
Verify issuance and dispensing of raw materials and primary packaging materials against approved batch records.
Conduct routine in-process checks, sampling, and documentation as defined in BMR.
Carry out stage-wise Batch Manufacturing Record (BMR) review to ensure execution compliance.
Ensure proper shift-to-shift handover documentation and reporting.
Quality Control Coordination
Collect in-process, finished product, and microbiological samples and ensure timely submission to QC.
Review electronic records and audit trails for equipment such as autoclaves, sterilizers, and filter integrity machines.
Quality Systems and Regulatory Compliance
Ensure adherence to GMP and Good Documentation Practices (GDP).
Maintain data integrity across logbooks, electronic records, and supporting documentation.
Support investigations related to product complaints, deviations, non-conformities, and OOS cases.
Execute approved Corrective and Preventive Actions (CAPA) within defined timelines.
Raise and track Document Change Requests (DCR) and Change Control Management (CCM) until closure.
Prepare and review Standard Operating Procedures (SOPs).
Process Validation and Data Analysis
Track Continued Process Verification (CPV) programs.
Prepare Minitab files and perform statistical data analysis for CPPs and CQAs.
Report abnormalities or process gaps to Supervisor or Shift Lead.
Systems and Equipment Management
Maintain admin logins and user access control for applicable equipment.
Initiate batch numbers in BaxLIMS after verification of manufacturing and expiry dates.
Approve preventive maintenance activities and risk assessments in MAXIMO.
Perform impact assessments for breakdown maintenance and approve activities in system.
Manage stock blockage or un-blockage in system as required.
Operational Support
Perform periodic building inspections with the Admin team.
Escalate failures or abnormal notifications for timely resolution.
Perform 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, GDP, CAPA, OOS, Change Control, and Data Integrity requirements.
Experience in BMR review, LIMS systems, statistical tools such as Minitab, and maintenance systems like MAXIMO.
Strong analytical, documentation, and communication skills.
Core Competencies
Detail-oriented and compliance-driven mindset
Strong critical thinking and problem-solving skills
Collaborative and cross-functional coordination ability
Continuous learning attitude with regulatory awareness
Equal Employment Opportunity
Baxter is an equal opportunity employer and considers all qualified applicants without regard to legally protected characteristics. Reasonable accommodations are provided for individuals with disabilities during the recruitment process.
This Senior Executive I – Quality Assurance role is well-suited for professionals seeking growth in pharmaceutical quality systems, regulatory compliance, and manufacturing quality operations within a globally recognized healthcare organization.
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