Collins McNicholas

This is a great opportinity to supervise a team of validations specialists in cold chain management responsible for review and approval of Initial and Continuing validation and qualification documentation for QA Validation (Thermal mapping of CTU’s/warehouse and shipping validation).

The sucessful candidate will be responsible for ensuring that systems and processes are qualified and/or validated in accordance with regulatory requirements and company manufacturing standards.

Responsibilities:

  • Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
  • Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
  • May prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.
  • Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
  • Reviews, edits and approves change control and SOPs.
  • Collaborates with functional departments to resolve issues. 
  • May review, edit and approve HEPA certification reports, Automation performance evaluation reports, and other reports or documentation submitted to the department.
  • May train/advise less experienced Specialists and Technicians.
  • May supervise, provide direction and assign work to Validations Specialists and/or Technicians to meet goals and deadlines.
  • Assesses quality system documentation for completeness and accuracy, and dispositions documentation
  • Manages projects and prepares status reports. 
  • Interacts with Automation/Process Engineering for managing changes during qualification window.
  • Strong communication/presentation skills during internal/external audits.

Requirements:

  • BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; will substitute relevant experience for education.

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

 

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