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Associate, Qa – In-Process Quality Assurance

2 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🏷️ Position Title:

Associate, QA – In-Process Quality Assurance (IPQA)
Req #: JR - 173921
Location: Ahmedabad, Gujarat, India
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🧭 Position Overview

As part of Baxter’s Quality Assurance team, the IPQA Associate plays a critical role in ensuring product quality and compliance during manufacturing and packaging. This role supports real-time quality oversight, in-process checks, sampling, documentation, and deviation management—helping to uphold Baxter’s mission of saving and sustaining lives.


🔍 Key Responsibilities

🏭 In-Process QA Operations:

  • Perform line clearance activities during various stages of manufacturing and packaging.

  • Verify raw materials and packaging materials (type and quantity) as per batch records.

  • Execute in-process checks, sampling, periodic verifications, and documentation per BMR.

  • Collect in-process and finished product samples and ensure timely submission to QC/Micro labs.

📋 Documentation & Compliance:

  • Review and verify equipment electronic records and audit trails (e.g., autoclave, sterilizers).

  • Ensure destruction of documents as per SOP and Good Documentation Practices (GDP).

  • Maintain compliance with data integrity, GMP, and GDP standards.

  • Assist in investigations, deviations, and complaints, supporting CAPA implementation.

  • Review batch manufacturing records (BMR) stage-wise for compliance.

📈 CAPA, SOPs, and Change Control:

  • Execute and track Corrective and Preventive Actions (CAPA) within defined timelines.

  • Raise and manage Document Change Requests (DCRs) and Change Control (CCM).

  • Prepare and review Standard Operating Procedures (SOPs).

🧪 Continuous Process Verification (CPV):

  • Track CPV programs using statistical tools (e.g., Minitab).

  • Collect and analyze data on Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

  • Report abnormalities and support process improvements.

🔧 Systems & Maintenance Oversight:

  • Maintain and manage user logins and access for equipment (admin login, access controls).

  • Approve preventive maintenance and impact assessments in MAXIMO.

  • Perform impact assessments for breakdowns and support approvals.

  • Manage material A.R. numbers and stock blockage/unblockage in systems.

🔄 Shift & Site Activities:

  • Ensure smooth shift handover and documentation in logbooks.

  • Report any abnormalities or failures for immediate escalation.

  • Conduct building inspections in collaboration with the Admin team.


👤 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 from scams by reading our Recruitment Fraud Notice.


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