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