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I&D Operational Excellence Specialist

I&D Operational Excellence Specialist

ConfidentialMumbai, India
4 days ago
Job description

JOB DESCRIPTION :

  • Primary Job Function : Training management and Governance for Innovation &Development functions including Medical, Clinical, Product Development and Regulatory.
  • Core Job Responsibilities :

Training

  • Ensure implementation of training activities
  • Support implementation and maintenance of documentation and I&D learning management systems (ISOtrain)
  • Manage I&D training metrices.
  • Maintain I&D user training matrix and curricula.
  • Prepare I&D quality system documents and liaise with Quality group to prepare document
  • Content upload / course creation in training system (ISOtrain).
  • Support preparation of onboarding packages for I&D. Assign trainings in the system.
  • Act as super user for identified systems like ISOtrain, DARIUS, I&D Training Matrix Platform, etc.
  • System set up of ISOtrain training records for profile creation, curricula assignment, and other activities.
  • Governance
  • Support compliance and quality control activities for Global I&D functions in scope - tracking and conducting self-inspection activities in line with department requirements.
  • Update department quality and compliance metrics.
  • Ensure I&D records comply with global guidelines and applicable regulations.
  • Perform quality control review of documents (e.g. check content consistency, pagination, spelling grammar, referencing, formatting etc.)
  • Support internal and external inspection activities as required.
  • Position Accountability / Scope :

  • Responsible for leading I&D training activities.
  • Responsible for document quality control reviews & self-inspection activities
  • Internal stakeholders : Integration and Strategic Excellence, Medical Affairs, Clinical Development, Pharmacovigilance, I&D Quality, Regulatory Affairs, Product Innovation & Development, Office of Ethics and Compliance. (Global, Regional and Local) External stakeholders' business partners (contractors, consultants, vendors)
  • Minimum Education :
  • Post Graduate Diploma in Quality Assurance for Food and Pharmaceutical Industry
  • Bachelors / Master's in life sciences
  • Minimum Experience / Training Required :
  • 6+ years of experience In Quality Management System and Training Management.

    Relevant experience in training management for larger group will be appreciated.

    Technical know-how of excel usage to manage metrics analysis is required.

    The base pay for this position is

    N / A

    In specific locations, the pay range may vary from the range posted.

    JOB FAMILY :

    Regulatory Operations

    DIVISION :

    EPD Established Pharma

    LOCATION :

    India Mumbai : BKC Building

    ADDITIONAL LOCATIONS :

    WORK SHIFT :

    Standard

    TRAVEL : Not specified

    MEDICAL SURVEILLANCE :

    Not Applicable

    SIGNIFICANT WORK ACTIVITIES :

    Not Applicable

    Skills Required

    Excel, isotrain

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