Validation Specialist Ireland

Há 6 dias

São Paulo, São Paulo, Brasil PSC Biotech Corporation Tempo inteiro

Job Title: Validation Specialist Ireland

Job Summary:

PSC Biotech Corporation is seeking a highly skilled Validation Specialist to join our team in Ireland. As a Validation Specialist, you will play a critical role in ensuring the quality and compliance of our products by designing, authoring, reviewing, and executing qualification and validation documentation and cycle development studies.

Key Responsibilities:

  • Design and author qualification and validation documentation and cycle development studies in line with standard approval processes.
  • Execute and develop change controls, resolving technical issues encountered during study execution.
  • Engage with Production, Maintenance, and Quality representatives in assigned areas of operations during execution of Cycle Development & Performance Qualification activities.
  • Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Represent the validation team at global technical forums and 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.
  • Support regulatory audits and submissions as required.
  • Work collaboratively to drive a safe and compliant culture in site.

Requirements:

  • 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.
  • Proven track record in delivering excellence.
  • Knowledge of CTU equipment qualification, thermal mapping equipment, and thermal mapping skills.
  • Exception / Deviation Management and Change Control.
  • Demonstratable experience of leading technical related projects.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
  • Evidence of continuous professional development.
  • Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  • 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.
  • Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.

Qualifications & Education:

  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.

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