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/ Masters 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
Required Experience:
IC