Ll01-030524 Project Manager for Cqv Documentation

4 days ago


Raritan, United States Validation & Engineering Group Full time

**_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.
- 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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