Validation Expert

2 weeks ago


Carlow, Ireland Claran Consultants Ltd Full time

Job Description

We are seeking a highly skilled Validation Engineer to join our team at Claran Consultants Ltd. This is an exciting opportunity for candidates interested in a new challenge in a GMP regulatory environment.

The successful candidate will support several aspects of validation, including design/author/review/approve/execute qualification/validation documentation and cycle development studies, execution/development of change controls, and technical input into quality notifications.

Key Responsibilities:

  • Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
  • Design/Author/Review/Approve/Execute Execution/development of change controls.
  • Resolving technical issues encountered during study execution.
  • Engagement with Production, Maintenance, and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
  • Technical input into quality notification by authoring/reviewing/approving investigations.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
  • Serve as validation representative for cross-functional projects and represent the validation team at global technical forums.
  • Drive compliance of Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactively highlighting any issues around compliance.

Requirements:

  • In order to excel in this role, you will have considerable experience in a comparable role, with experience operating as an individual contributor adding value to the business in a GMP manufacturing setting.
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
  • Demonstrable experience of leading technical-related projects.
  • Knowledge of CTU equipment qualification, thermal mapping equipment, and thermal mapping skills.
  • Exception / Deviation Management and Change Control.
  • Ability to analyze and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications required.

About Us

Claran Consultants Ltd is a leading consulting firm providing expert services in GMP validation, compliance, and process improvement. We are committed to delivering excellence and supporting our clients in achieving their goals.



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