I&D Operational Excellence Specialist

6 - 8 years

0 Lacs

Posted:2 days ago| Platform: Foundit logo

Apply

Work Mode

On-site

Job Type

Full Time

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

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

RecommendedJobs for You