Instagram
youtube
Facebook

Assoc, Quality - Ipqa

0-2 years
Not Disclosed
10 March 21, 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

Assoc, Quality - IPQA (JR 160937)

Company: Baxter
Location: Ahmedabad, Gujarat, India

Overview:
As a member of the Baxter Quality team, you will play an essential role in ensuring patient safety by maintaining quality throughout the product lifecycle. Quality roles provide opportunities for growth, learning, and a successful career that impacts people’s lives daily.

What You'll Be Doing:

  • Take instructions from the Supervisor and Shift Lead to perform shift activities.

  • Verify the correct raw material, primary packaging material, and quantities issued and dispensed as per approved batch records.

  • Perform line clearance activity at various manufacturing and packaging stages as defined in the BMR.

  • Conduct routine in-process checks, sampling, periodic verification, online documentation, and escalate any nonconformances to Shift Lead and Supervisor.

  • Collect and submit in-process, finished product, and other samples to QC/Micro departments timely.

  • Review and verify electronic records/audit trails and printouts of equipment like autoclaves, sterilizers, and filter integrity machines.

  • Ensure proper documentation destruction as per approved procedures.

  • Maintain compliance with GDP for logbooks, records, and supporting documents related to manufactured products.

  • Support Shift Lead or Supervisor in investigating product complaints, non-conformities, or out-of-specification incidents.

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

  • Raise Document Change Requests (DCR) and Change Control Management (CCM) and ensure timely closure as per SOPs.

  • Prepare and review SOPs.

  • Conduct stagewise BMR reviews for batch execution compliance.

  • Track the CPV Program, prepare Minitab files based on production plans, and perform data analysis for CPPs/CQAs. Report abnormalities to the Supervisor/Shift Lead.

  • Maintain and manage admin logins for applicable equipment, provide new logins, and periodically verify and control user access.

  • Initiate batch numbers in BaxLIMS after verifying manufacturing and expiry dates.

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

  • Ensure proper shift handovers and maintain records in the Shift Charge Handover format/logbook.

  • Communicate any failure or abnormal notifications to the Supervisor/Shift Lead for timely resolution.

  • Perform impact assessments of breakdown maintenance and approve activities in MAXIMO with risk assessment reviews.

  • Manage material A.R. No. stock blockage/unblockage in the system.

  • Conduct periodic building inspections with the Admin team.

  • Handle any additional responsibilities assigned by the Shift Lead or Reporting Manager.

What You'll Bring:

  • Strong attention to detail, analytical thinking, and collaborative mindset.

  • Ability to work independently and take ownership of assigned tasks.

Reasonable Accommodations:
Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance due to a medical condition or disability, please click
here to provide your contact information and details.

Recruitment Fraud Notice:
Baxter has identified incidents of employment scams where fraudulent parties pose as Baxter employees to steal personal information. To protect yourself, review our Recruitment Fraud Notice.