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Project Manager with Regulatory GMP Auditing Experience
Ref No.: 17-01536
Location: Hopewell, New Jersey
Position Type:Contract
Start Date: 11/08/2017
PROJECT MANAGER WITH REGULATORY GMP AUDITING EXPERIENCE
HOPEWELL, NJ

Project Description:
  • The candidate will be responsible for assisting in processes related to the Client TSE (Transmissible Spongiform Encephalopathies) program.
  • Develop an in-depth knowledge of global TSE requirements and be able to apply these requirements to the job.
  • Maintain TSE information repositories within Client.
  • Effectively network with key business partners to achieve assigned objectives.
  • Evaluate documentation for compliance to current requirements and help with securing documentation for the preparation of Client TSE Regulatory Compliance product statements.

Required Skills:
  • Excellent oral and written communication skills.
  • Proficient navigation of electronic systems, (e.g., MS Excel, and Adobe Acrobat) including formatting and electronic management of data and information.
  • The candidate will have demonstrated ability to be a strong team member with the ability to drive projects to completion on time.
  • Knowledge of global BSE/TSE regulations and guidances a plus.
  • Knowledge of product formulation and manufacturing processes desirable.
  • Ability to handle multiple projects and prioritize work independently.
  • Basic understanding of the drug development process plus an integrated view of the technical, manufacturing and commercial aspects of the pharmaceutical business.
  • Minimum of 2-5 years of experience in the pharmaceutical industry with a BS degree in a scientific discipline, chemistry or pharmacy preferred.
  • Experience in GMP auditing and/or CMC regulatory a plus.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01536
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE