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Abbott

I&D Operational Excellence Specialist

Reposted 8 Days Ago
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In-Office
Mumbai, Maharashtra
Senior level
In-Office
Mumbai, Maharashtra
Senior level
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.
The summary above was generated by AI

     

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

     

     

     

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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