Collins McNicholas

Responsibilities

  • Provide Process Descriptions and Facility Fit Comparisons.
  • Assess manufacturing requirements prior to the transfer of processes into new manufacturing facilities.
  • Assist in the writing and review of manufacturing/batch records, and SOPs if necessary.
  • Provide manufacturing descriptions and technical evaluations for master files.
  • Gather, trend, and analyse process generated data
  • Generate process evaluation reports and process transfer documentation from Master File Data.
  • Provide technical support to improve understanding of the responsibility of contract manufacturer
  • Ensure all tasks are performed within cGMP guidelines.
  • Support Technical Agreement implementation
  • Build process knowledge repository/database
  • Arrange support when necessary during manufacturing operations.

 

Required Education / Experience / Knowledge / Skills

  • BS Life Sciences or Engineering with 1+ years of experience.
  • Ability to communicate clearly the timelines and important milestones.
  • Ability to adapt to a quickly changing environment.
  • Knowledge of cGMP and other applicable regulations.
  • Ability to effectively communicate issues and ideas with peers and with management.
  • Ability to facilitate meetings with cross-functional teams.
  • Excellent interpersonal, written, and oral communication skills.
  • Ability to build effective working relationships throughout the organization

 

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

 

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