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Work/Life Balance

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challenging projects

Insurance

Are you a seasoned professional in training management and quality control within the medical and clinical affairs sector? If you have a strong background in Quality Management Systems (QMS) and training management, this role as an I&D Operational Excellence Specialist could be your next career move. Located in Mumbai, this position offers an exciting opportunity to manage training activities and ensure governance and compliance across the Innovation and Development (I&D) functions, including Medical, Clinical, Product Development, and Regulatory.

Core Job Responsibilities

As the I&D Operational Excellence Specialist, you will be responsible for overseeing the training management and governance processes for the I&D functions within the organization. Your key responsibilities include:

Training Management

  • Implementation of Training Activities: Lead the execution of training programs and ensure they align with organizational needs.
  • Documentation & Learning Systems: Support the implementation and maintenance of training systems (e.g., ISOtrain) and manage I&D training metrics.
  • Matrix Management: Maintain the I&D user training matrix and curricula, ensuring all training activities are up to date and in line with company standards.
  • Content Creation and Upload: Create and upload content for courses in the training system and assign training as part of the onboarding package for new I&D members.
  • System Super User: Serve as the super user for training systems such as ISOtrain, DARIUS, and the I&D Training Matrix Platform.

Governance & Quality Control

  • Compliance & Quality Control: Support compliance and quality control activities across the Global I&D functions, including tracking and conducting self-inspection activities.
  • Document Review: Ensure that I&D records are in compliance with global guidelines and regulations. Perform quality control reviews of documents to check for content consistency, formatting, grammar, and more.
  • Inspection Support: Assist with internal and external inspections, ensuring that all required documents and systems are in place and meet compliance standards.

Position Accountability/Scope

  • Training Management: You will be responsible for leading the I&D training activities and ensuring their smooth execution.
  • Document Quality Control: Ensuring that all documents meet the highest quality standards through detailed reviews and managing self-inspection activities.
  • Stakeholder Collaboration: Work closely with internal teams such as Medical Affairs, Clinical Development, Pharmacovigilance, Regulatory Affairs, and Product Innovation & Development, as well as external partners including contractors, consultants, and vendors.

Minimum Education & Qualifications

  • Post Graduate Diploma in Quality Assurance for Food and Pharmaceutical Industry or equivalent.
  • Bachelor’s or Master’s degree in life sciences or related fields.

Experience Required

  • 6+ years of experience in Quality Management Systems and Training Management, preferably within medical or pharmaceutical industries.
  • Experience in managing training for large groups will be highly appreciated.
  • Technical Know-how: Proficiency in using Excel for metrics analysis and reporting.

Skills & Competencies

  • Strong understanding of Quality Management Systems (QMS) and training management within the I&D functions.
  • Excellent attention to detail for document review and quality control tasks.
  • In-depth knowledge of ISOtrain and other training platforms such as DARIUS.
  • Strong communication skills to collaborate effectively with global teams and external stakeholders.
  • Ability to manage compliance, self-inspection activities, and internal audits to ensure regulatory adherence.

Application Link

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