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Eso Change Coordinator

3 months ago

Hyderabad, Telangana, India Novartis Full time
392067BR

ESO Change Coordinator:

India

About the role
Location - Hyderabad, India

About the Role:


To support and ensure consistency and implementation of assigned Third Parties change projects from initiation to execution end to end, in order to ensure timely implementation of changes and supply to the markets in compliance with regulatory and cGMP requirements.


Key Responsibilities:

  • Accountable for the interfunctional evaluation and implementation phases of change requests, considering the most effective implementation strategy, cGMP's, regulatory requirements, Corporate Quality Manual, Novartis policies and cost effectiveness. Set priorities for change requests in line with the relevant boards.
  • To support project teams in order to ensure project management according to the agreed strategy and timelines
  • To ensure efficient, timely and clear communication to all involved partners (onsite and off
- site incl. to global product lifecycle leader and RA CMC) as required for flawless project execution in collaboration with project leader

  • To communicate project progress and deviations as appropriate in collaboration with project leader, when available. To elaborate risk mitigation plans as appropriate in collaboration with project leader
  • To solicit input from site functions and to ensure that site specific information is made available in global projects and in relevant databases
  • Needs to ensure that assessment of supply is performed
  • To support process experts in evaluation, planning and execution for main and sub processes (e.g. CAR, capacity planning, resources, etc.)
  • Actively participate in the decision making process whether a change has crossdivisional impact or not.

Commitment to Diversity & Inclusion:

  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Role Requirements

Essential Requirements:

  • A minimum of 5 years of experience in regulatory environment, production, or lab.
  • Experience in production/QA/QC is a beneficial advantage
  • Excellent spoken and written English

Desirable Requirements:

  • University or academic degree in Chemistry, Biology, Pharmacy or equivalent

Division
Operations

Business Unit

SUPPLY CHAIN

Work Location
Hyderabad, AP

Company/Legal Entity
Nov Hltcr Shared Services Ind

Functional Area
Technical Operations

Job Type
Full Time

Employment Type
Regular

Shift Work
Yes

Early Talent
No