The role involves managing training and governance for Innovation & Development, ensuring compliance, quality control, and documentation management. It requires overseeing training metrics, preparing quality documents, and supporting inspection activities.
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/AIn 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
Top Skills
Darius
Excel
Isotrain
Quality Management System
Abbott Mumbai, Maharashtra, IND Office
16th Godrej BKC Plot C, Bandra Kurla Complex, Bandra East, एवेन्यू 3, G Block BKC, Bandra East, Mumbai, Maharashtra, India, 400051
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