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Job Details

All Jobs / Req# NOVRJP00011988
Req Number:
NOVRJP00011988
Req Title:
Team and Project Support
Client:
A Major Pharma Company
Work Address:
Indianapolis, IN
Req Release Date:
07/05/2024
Duration:
6 months
Hours a week:
40 Hours
Position Summary

Job Purpose:

  • Write, summarize, and drive project change controls for cleanroom, clean utilities, EMS and associated systems.
  • Laydown clear plan for drafting, reviewing, and pre-approving commissioning and qualification documents for cleanroom, clean utilities, EMS, and other associated systems.
  • Execute commissioning and qualification activities and resolve deviations (if any) in a timely manner.
  • Work with project team to ensure all activities are carried out in accordance with the project timeline.
  • Ensure all documents are written in accordance with the Client's Quality Manual and procedures.
  • Ensure all utilities related drawings are available and updated in the commissioning and qualification documents.
  • Develop required procedures and handover to system owner in a timely manner.
  • Coordinate with various internal and external stakeholders to refine the list of activities scheduled and maintain the best possible granularity in the schedule.
  • Ensure project activities are sequenced in the most logical manner ensuring completion of pre-requisites timely and orderly.
  • Escalation of potential issues that may arise from time to time during the execution of project activities and collaborate with the cross-functional teams towards resolution.
  • Be the go-to person in case of requests with regard to cleanroom or clean utilities.

Major Accountabilities:

  • Drafting, reviewing and pre-approval of protocols in a timely manner
  • Adherence to overall project schedule
  • Ensure all commissioning and qualification protocols are compliant to the Client's quality manual and site procedures.
  • Fosters an environment that enables the most efficient and effective work processes to achieve project objectives and milestones.
  • Implementation of and compliance with all the guidelines and requirements for safe work, environment protection and property protection.

Key Performance Indicators – KPIs:

  • Timely and complete commissioning and qualification packages for the systems.
  • Adherence to project schedule of activities
  • Compliance with the Client's Quality Manual and RLT Site SOPs.
Qualifications:
  • Education:Minimum: Degree in Science and Certification in Project Management (preferred).
  • Extensive project management experience may substitute the need for a degree.
  • Languages: Fluent in English; Second Language preferred.

Experience:

  • High performing, credible professional, with a track record of successfully coordinating cross functional projects and teams.
  • Cultural awareness and sensitivity; ability to network and communicate with various levels of the organisation.
  • Fair understanding of technical and business principles and processes of medicine manufacture and regulatory requirements attained in various functions / areas of pharmaceutical industry.
  • >6 years project management experience, of this, >2 years within similar role and complexity; experience in Health Care / Pharma Industry preferred.
  • Strong planning capabilities (decision making, result oriented, challenge capability, negotiation, supporting others, stakeholder mgt, change mgt, working in a matrix organization).
  • Strong proficiency in Microsoft Excel, PowerPoint, and MS Project.
  • Strong verbal communication and presentation skills.
  • Fexibility and adaptability to change.
  • Learning agility and ability to work in a complex and rapidly changing envirnomnemt.
  • Basic uderstanding of regulatory and legal requirements.
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