Mumbai, Maharashtra, India
18 hours ago
I&D Operational Excellence Specialist

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 activitiesSupport 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 documentContent 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.GovernanceSupport 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 activitiesInternal 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 IndustryBachelors/ 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.

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