drjobs I&D Operational Excellence Specialist

I&D Operational Excellence Specialist

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1 Vacancy
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Job Location drjobs

Mumbai - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

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/ 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

Employment Type

Full-Time

Company Industry

About Company

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