QA CMO Associate

  • Cork
  • Temporary 24 Months
  • JO-1905-64454_1557304749

Summary

Responsibilities

  • Assist with the oversight of the supply chain, manufacture and packaging of products in various Contact Manufacturing Organizations.
  • Review of Manufacturing/Packaging batch records and Quality Control documentation prior to recommending batch release.
  • Review and approve standard operating procedures, master batch records and product specifications.
  • Provide Quality oversight of deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
  • Proactively support the continuous improvement of quality systems by identifying and building in efficiencies from a systematic and compliance perspective.
  • Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
  • Assist with regulatory inspections.
  • Artwork Approval
  • Support the following activities, as appropriate:
    • Processing external customer complaints
    • Quality Deviations and Laboratory Investigations
    • Change Controls
    • New or updates to relevant quality agreements
    • Validation activities
    • Perform Audits internal & external
    • Annual Product Reviews
    • Recalls and/or notification of events to regulatory agencies

Requirements

  • A minimum of 5 years' experience in a cGMP regulated drug substance, drug product manufacturing and/or packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
  • Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
  • Excellent interpersonal skills with the ability to work as part of a dynamic team and efficiently engage both interdepartmentally and with external CMO's.

Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned

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