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I&D Operational Excellence Specialist

6+ years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.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

I&D Operational Excellence Specialist

Location: Mumbai, India
Category: Regulatory Affairs


Primary Function

Manage training and governance for Innovation & Development (I&D) functions, including Medical, Clinical, Product Development, and Regulatory.


Core Responsibilities

Training Management

  • Ensure implementation of training activities for I&D functions.

  • Support maintenance and use of I&D Learning Management Systems (e.g., ISOtrain).

  • Manage and maintain I&D training matrices and curricula.

  • Prepare and upload content, create courses in training systems.

  • Prepare onboarding packages and assign trainings in the system.

  • Act as super user for systems such as ISOtrain, DARIUS, and I&D Training Matrix Platform.

  • System setup of ISOtrain records including profile creation, curricula assignment, and other related activities.

  • Liaise with Quality Group to prepare I&D quality system documents.

Governance & Compliance

  • Support compliance and quality control activities for global I&D functions.

  • Track and conduct self-inspection activities per departmental requirements.

  • Update department quality and compliance metrics.

  • Ensure I&D records comply with global guidelines and applicable regulations.

  • Perform quality control review of documents (content consistency, pagination, spelling, grammar, referencing, formatting).

  • Support internal and external inspection activities as required.


Position Accountability / Scope

  • Lead I&D training activities.

  • Conduct document quality control reviews and self-inspection activities.

  • Collaborate with internal stakeholders: Integration & Strategic Excellence, Medical Affairs, Clinical Development, Pharmacovigilance, I&D Quality, Regulatory Affairs, Product Innovation & Development, Office of Ethics & Compliance (Global, Regional, Local).

  • Coordinate with external stakeholders: business partners, contractors, consultants, vendors.


Qualifications

  • Education:

    • Post Graduate Diploma in Quality Assurance for Food and Pharmaceutical Industry

    • OR Bachelor’s / Master’s in Life Sciences

  • Experience:

    • Minimum 6+ years in Quality Management System and Training Management

    • Experience in training management for large groups preferred

    • Proficiency in Excel for metrics analysis