QA Operations Lead

Employment Type : Permanent
Salary :
Location : Dublin
Reference : RJ19265
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QA Operations Lead


A global bio pharmaceutical group is currently looking for an experienced Quality Assurance Professional to join the team in the role of QA Operations Lead. This fantastic opportunity will allow you the chance to work for a recognised and highly reputable organisation.


The QA Operations lead will report to the QA manager and will assist in ensuring that company operations and operating procedures are in compliance with all appropriate cGMP regulations and guidelines.  Will provide ongoing supervision of compliant subsystems of the site Quality Management System.  Contribute to Quality processes / initiatives at a local and global level as required.


Duties / Responsibilities:

  • Oversee and approve investigations, out of specification and unplanned events workflows to ensure they are performed correctly
  • Release of Semi-finished goods and APIs
  • Manage and Perform internal cGMP walk-downs and Audits of multiple operations
  • Support on-site inspections by all external regulatory bodies
  • Compilation, Review and Approval of cGMP Documentation
  • Generation and review of Annual Product Quality Reviews
  • Conduct training of QA team, where appropriate
  • To work as part of the QA Team to support the production plan including Investigation review and release and shipping of SFG and API
  • Assist in Change Control Activities-Documentation, Process, Equipment, Facility, Computer and Analytical act as back up for the Change Control Coordinator
  •  Assist in Validation Activities-Process, Equipment, Facility and Computer
  • Participation in departmental enterprise excellence initiatives
  • Ensure Compliance with site EHS systems and procedures e.g. permit to work systems

Incident/Accident Investigation procedures etc.


Key Requirements:

  •  At least 5 years relevant experience working within QA
  •  BSc. In Science
  •  Languages – English


Technical Competencies:

  • 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 in API sites

There is an attractive compensation package for suitable candidates.


For more information please apply through the link provided for the attention of Robert Jones or call Osborne on 041 986 5058

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