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Sr Assoc, Quality - T&D

0-2 years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm 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: Sr. Assoc, Quality - T&D
Location: Ahmedabad, Gujarat, India


Company Overview:

At Baxter, we are united by our mission to save and sustain lives. Our products and therapies are found in nearly every hospital worldwide, and for over 85 years, we have pioneered significant medical innovations that improve healthcare globally. Working at Baxter means you’ll feel a sense of purpose, knowing that your contributions improve outcomes for millions of patients. Join us at the intersection of saving lives and advancing healthcare, where your work accelerates our mission.


Position Summary:

As a Sr. Associate, Quality - T&D, you will be instrumental in monitoring and managing the ongoing Quality Management System (QMS) event-based training at Baxter. You will ensure the effectiveness of training triggered by Non-Conformance, CAPA, Market Complaints, SOP revisions, and more. This role also includes managing the Learning Management System (LMS), overseeing employee onboarding and orientation, and executing training programs on Good Manufacturing Practices, Data Integrity, and other relevant topics.


Key Responsibilities:

  • Training Management:

    • Monitor and manage QMS event-based training, ensuring effectiveness and compliance.

    • Facilitate new employee orientation and ensure timely completion of required training for assigned roles.

    • Manage the Learning Management System (LMS), including the maintenance of courses, quizzes, curricula, assignments, and history credits.

  • Content Development:

    • Develop training content based on the Annual Training Calendar, campaigns, and quality-related requirements.

    • Execute training programs on Good Manufacturing Practices, Data Integrity, Trainer Qualification, and other necessary topics.

  • Training Effectiveness:

    • Measure the effectiveness of training through On-Job Training (OJT), surveys, feedback, and audits.

    • Align effectiveness checks in line with Baxter's global standards.

    • Track and ensure timely completion of all assigned training.

  • Human Element and Error Management:

    • Assess and trend human errors, documentation errors, or any factors related to training or human performance.

    • Define control measures to avoid reoccurrence.

  • Employee Engagement and Culture:

    • Lead and assist in quality culture initiatives, campaigns, and employee engagement programs.

  • Contingent Workers and Qualifications:

    • Track and monitor contingent workers' training processes, ensuring qualifications are up to date as required.


Preferred Educational Qualification:

  • Bachelor's or Master's degree in Pharmacy or Science.