Clinical Project Manager

3 weeks ago

Indianapolis, United States Tech Observer Full time

Title: AS&T Manager

Location: Indianapolis, IN

Duration: 8+ Months


Description:

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 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.


Minimum: Degree in Science and Certification in Project Management (preferred). Extensive project management experience may substitute the need for a degree.


Skills:

Fluent in English; Second Language preferred

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

Flexibility and adaptability to change.

Learning agility and ability to work in a complex and rapidly changing environment.

Basic understanding of regulatory and legal requirements

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