Project Manager for CQV Documentation Project

2 months ago


Raritan, United States Validation & Engineering Group Inc. 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.
  • 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.


  • 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...

  • Project Manager

    2 weeks ago


    Raritan, United States Sthree Full time

    Exciting Project Management consultant opportunity with Johnson & Johnson in Raritan, NJ. This opportunity is ideal for PMs with supply chain and pharma/OTC/consumer goods experience. Title: Project Manager, Life Cycle Management Industry: Pharma/Med Tech Work Mode: Hybrid (1-3 days onsite/week depending on project need) Structure: Longterm contract...

  • SAP Project Manager

    3 weeks ago


    Raritan, United States Diverse Lynx Full time

    SAP Project Manager Raritan, NJ (Day 1 onsite) Job Description § A minimum of a Bachelor's degree § Expertise on managing SAP Migration projects as a Project manager § Sound knowledge on organizational IT Infrastructure and its architecture § Experience in IT Project/Program management for minimum 5 year § Strong knowledge on managing project finances....


  • Raritan, United States Joulé Full time

    Title: Medical Affairs Project Manager Location: Must be local to NJ. 2 days onsite weekly in Raritan, NJ Type: Salaried with full benefits Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring Senior Medical Affairs Project Manager with 3+ years industry experience. If you want to be a part of this groundbreaking work, please...


  • Raritan, United States Legend Biotech US Full time

    Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...


  • Raritan, United States Johnson & Johnson Full time

    Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Control (QC) Projects Lead (CAR-T) in Raritan, NJ! The QC Projects Lead will work directly with the Quality Control Excellence Manager, organizing and connecting with stakeholders on QC projects, change controls and method transfers. Striving for...


  • Raritan, United States Kelly Science, Engineering, Technology & Telecom Full time

    Clinical Project Scientist (Oncology)The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials.Responsibilities:The following responsibilities will be demonstrated in varying degrees of participation and leadership: Partners with Study Responsible Physician (SRP) to provide...


  • Raritan, United States Kelly Science, Engineering, Technology & Telecom Full time

    Clinical Project Scientist (Oncology)The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials.Responsibilities:The following responsibilities will be demonstrated in varying degrees of participation and leadership: Partners with Study Responsible Physician (SRP) to provide...


  • Raritan, United States Actalent Full time

    Great opportunity for candidates with experience creating and maintaining SOPs and documentation in a regulated environment! Description: • Support the Site Instrument Officer during execution to the Site Calibration Procedure • Performs procedural change management tasks under the direction of the Site Instrument Officer. • Ensure the Site Calibration...

  • Project Coordinator

    2 weeks ago


    Raritan, United States Kelly Services Full time

    Kelly Science and Clinical FSP is currently seeking a Project Coordinator - Learning and Development for a long-term engagement with one of our Global Pharmaceutical clients and is a remote position. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is...

  • Project Coordinator

    2 weeks ago


    Raritan, United States Kelly Services, Inc. Full time

    Kelly Science and Clinical FSP is currently seeking a Project Coordinator - Learning and Development for a long-term engagement with one of our Global Pharmaceutical clients and is a remote position. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is...

  • Document Specialist

    7 days ago


    Raritan, United States Actalent Full time

    Description: •Perform database queries regarding usage of gauges or measurement devices that have failed calibration •Report on status of Corrective Actions and pending resolution of calibration issues •Support R&D calibrations during internal and external audits •Provide regular communication with Engineering and Quality representatives as necessary...

  • Document Specialist

    2 weeks ago


    Raritan, United States Actalent Full time

    Description: Perform database queries regarding usage of gauges or measurement devices that have failed calibration Report on status of Corrective Actions and pending resolution of calibration issues Support R&D calibrations during internal and external audits Provide regular communication with Engineering and Quality representatives as necessary to...


  • Raritan, New Jersey, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Project Portfolio Lead, Advanced Therapies Supply Chain for our Janssen Pharmaceuticals, Inc. team At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less...


  • Raritan, United States Actalent Full time

    Description: • Support the Site Instrument Officer during execution to the site calibration procedure • Coordinate the activities associated with the non-conformance process by supporting engineers and gauge owners • Responsible for conducting multiple reviews for conformance • Perform database queries regarding usage of gauges or measurement...


  • Raritan, New Jersey, United States Actalent Full time

    : Support the Site Instrument Officer during execution to the site calibration procedure Coordinate the activities associated with the non-conformance process by supporting engineers and gauge owners Responsible for conducting multiple reviews for conformance Perform database queries regarding usage of gauges or measurement devices that have failed...


  • Raritan, United States Medasource Full time

    Publications ManagerRaritan, NJ (2-3 days onsite)12 month contract • Lead overall publication planning and strategy in collaboration with R&D Compound Development Team, Medical Affairs, Regional Teams, and Market Access colleagues. • Manage a team of external publication vendors for publication planning and execution.• Work collaboratively with Global...


  • Raritan, United States Medasource Full time

    Publications ManagerRaritan, NJ (2-3 days onsite)12 month contract • Lead overall publication planning and strategy in collaboration with R&D Compound Development Team, Medical Affairs, Regional Teams, and Market Access colleagues. • Manage a team of external publication vendors for publication planning and execution.• Work collaboratively with Global...


  • Raritan, United States Actalent Full time

    Description: Support the Site Instrument Officer during execution to the site calibration procedure Coordinate the activities associated with the non-conformance process by supporting engineers and gauge owners Responsible for conducting multiple reviews for conformance Perform database queries regarding usage of gauges or measurement devices that have...

  • Document Specialist

    2 weeks ago


    Raritan, United States Proempire LLC Vitamatic Full time

    **Job Overview**: An entry-level position to manage food safety and quality of incoming raw materials and finished goods to assure a high level of product quality within the established company/industry standards. **Responsibilities**: - Create, support, review, update, file, and issue-controlled documents after a full review of analytical raw lab data...