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GMP Change Control Manager in Lake Forest, IL at PointOne Recruiting Solutions

Date Posted: 9/1/2018

Job Snapshot

Job Description

GMP Change Control Manager


 


                Are you highly motivated, organized, and want to join a growing company in a fast-paced environment?  Do you enjoy working in a team atmosphere?  If you would like to be part of a successful team, then you could be what our client is looking for in their GMP Change Control Manager.  This is an excellent opportunity that offers a competitive compensation package.  If this is for you or someone you know, please forward a current resume to tim@pointonerecruiting.com    



Responsibilities – Change Control Manager



  • Will manage the development, implementation, and delivery of change control processes, including an electronic solution.

  • Responsible for design, development and delivery of training material for the change control process at the Corporate and Center levels.

  • Work with other departments to ensure that individual change control activities are conducted according to established standards and standard operating procedures (SOPs), also ensuring that all employees understand their job functions supported by the appropriate processes. 

  • Develop monthly metrics and trends for Quarterly Management Reviews.

  • Work collaboratively with the Centers and Corporate Office to implement the IT solution for Change Control.

  • Manage continual improvements of eQMs.


Job Requirements

Requirements – Change Control Manager


  • BS in Science/Applicable degree and 7 + years relevant pharmaceutical and regulatory experience.

  • Electronic Quality Management implementation and support experience 

  • Demonstrated experience of Change Control

  • Prefer knowledge of Aseptic Processing

  • Knowledge of technical writing and technical terminology including technical writing skills.  Ability to assess and communicate regulatory risks.

  • Knowledge of regulatory and industry guidelines and requirements.  

  • Knowledge of cGMPs, as well as sound quality and regulatory principles consistent with ‘best practices'.

  • Demonstrated knowledge of plant Quality Systems, plant data systems, preparing responses to audit observations and deviations, and corporate metric systems.


 


Apply Now!  Send resumes to tim@pointonerecruiting.com