Collins McNicholas

Collins McNicholas currently have an exciting opportunity for a QA Validation Manager – Cleaning & SIP with one of their clients in the Mid-West Region. This role is a permanent position.

 

Summary:  This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Specialists

The following are the key requirements for the role:

 

Responsibilities:

  • Manage, develop and build a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation. 
  • Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines. 
  • Ability to manage multiple and complex validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks. 
  • Lead technical and quality investigations. 
  • Collaborates with functional departments to resolve issues. 
  • Manage a cross-functional projects with many stakeholders
  • Reviews, edits and approves change controls, SOPs, reports and other documentation
  • Review and/or approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria 
  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. 
  • Trains/advises less experienced Specialists. 
  • May present at both internal and external (regulatory) audits if required.
  • Stays current with industry trends, regulatory requirement updates, and communicating same to team 
  • Performs other duties assigned by Management. 
  • Some travel may be required. 

Requirements:

  • BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; may substitute relevant experience for education. 
  • Previous team/people management experience essential. 
  • Previous cleaning validation and steam in place experience an advantage. 
  • Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage.  

For a confidential discussion on the above role please contact Michael O’Leary on 061-512270

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