LL01-030524 Project Manager for CQV Documentation Project

4 weeks ago


Somerville, United States Validation & Engineering Group Full time
Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Project Manager for CQV Documentation Project

Qualifications:

  • Bachelor's Degree in Science or Engineering.
  • Minimum of 5 years of experience in Project Management in direct pharmaceutical, medical device or biotechnology industries.
  • Experience in CQV in direct pharmaceutical, medical device or biotechnology industries.
  • Must be fully bilingual (English / Spanish) with excellent oral skills.
  • Must be proficient using MS Windows, Microsoft Project and Microsoft Office applications.
  • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
  • Available to work extended hours, possibility of weekends and holidays.

Skills:

  • Able to work with multiple projects at the same time.
  • At least 5 years on the pharmaceutical industry preferably with experience on CQV Projects, Document Control.
  • Efficient scheduling.
  • Proactive management.
  • Project Management experience.

Project Scope:

The resource should be able to:

  • Participate in daily meeting/forums regarding the assigned projects.
  • Participate on change control/events meetings.
  • Manage change controls to ensure implementation steps are completed on time and in compliance with requirements.
  • Participate and serve as facilitator and technical support for the CQV Documentation Project.
  • Report immediately any event of the assigned projects.
  • Complete event documentation, investigation and closing of implementation actions.
  • Perform installation and completeness verification of the activities.
  • Coordinate the activities for the day to ensure compliance with schedule and other project requirements.


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