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Assoc, Quality - Ipqa

3+ years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: Assoc, Quality - IPQA
Location: Ahmedabad, Gujarat, India


Company Overview:

At Baxter, we are driven by a shared commitment to saving and sustaining lives. Our innovative products and therapies are found in nearly every hospital around the world, and we’ve been pioneering medical advancements for over 85 years. Working with us means being part of a mission that improves healthcare outcomes for millions of patients. Your contributions directly impact people’s lives, creating a meaningful and purposeful career.


Position Summary:

As an Associate in Quality - IPQA, you will ensure the integrity of quality processes during manufacturing and packaging. Your role includes verifying the correct materials, performing routine checks, maintaining online documentation, and ensuring compliance with established standards and procedures. You'll also support investigations for non-conformities and product complaints, ensuring corrective actions (CAPA) are taken. This position requires proactive participation in maintaining compliance with quality standards and continuous process improvement.


Key Responsibilities:

  • Material Verification:

    • Verify correct raw materials, primary packaging materials, and quantities for batch records.

  • Line Clearance and Routine Checks:

    • Perform line clearance at various stages of manufacturing and packaging as outlined in the Batch Manufacturing Record (BMR).

    • Conduct routine in-process checks, sampling, and online documentation as specified in batch records.

  • Sampling and Documentation:

    • Collect in-process, finished product samples, and others for timely submission to QC/micro.

    • Ensure compliance with GDP for logbooks, online documents, and records, ensuring data integrity.

  • Issue Resolution:

    • Support shift leads and supervisors in investigating product complaints, non-conformities, or out-of-specification (OOS) issues.

    • Execute Corrective and Preventive Action (CAPA) within specified timelines.

  • Change Control and SOP Review:

    • Raise Document Change Requests (DCR) and Change Control Management (CCM), tracking their progress and ensuring timely closure.

    • Review and prepare Standard Operating Procedures (SOPs).

  • Data Analysis and Reporting:

    • Perform data analysis for Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

    • Track and report abnormalities or gaps to the supervisor or shift lead.

  • Maintenance and Access Control:

    • Maintain admin logins for applicable equipment and ensure periodic verification and access control.

    • Approve preventive maintenance activities in MAXIMO and conduct risk assessment reviews.

  • Shift Handover:

    • Ensure smooth handover of shift activities with detailed records in the Shift Charge Handover format/logbook.

    • Communicate failures or abnormalities to the supervisor for timely resolution.

  • Additional Responsibilities:

    • Perform impact assessments of breakdown maintenance and approve activities in MAXIMO.

    • Participate in building inspections with the Admin team and handle other responsibilities assigned by the shift lead or reporting manager.