Website Asset Recruitment

Asset Recruitment

The QA Chemist will report to the QA manager and will perform all the required Quality Assurance activities for the implementation of Manufacturing Execution System (MES) in compliance with all appropriate cGMP regulations and guidelines.

Responsibilities:

  • Perform the QA representative role in the development and implementation process of Manufacturing Execution System (MES) project.
  • Review of MES documentation, recipes and process flows; supporting MES change control
  • Complete the QA oversight to ensure the design and validation of the MES system meets cGxP, data integrity and site requirements
  • Review and approval of MES validation documents
  • Authoring, Review and Approval of cGMP Documentation associated with the MES project

Requirements:

  • Third Level Qualification in Science related discipline
  • 3 years relevant experience working within QA, including previous MES experience
  • Work with minimal supervision
  • Able to perform under pressure to competing demands and stakeholders
  • Strong customer focus
  • Perform work with highest levels of confidentiality and integrity
  • Knowledge of cGMP as it relates to API (Requirements of EMEA, FDA and ICH
  • In-Depth knowledge of quality systems and their maintenance / implementation
  • Team-working and communication skills
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