Validation Specialist Ireland
3 semanas atrás
We are excited to offer a fantastic opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will support several aspects of Validation, including Sterilisation, Cleaning, Isolator, Controlled Temperature Units, and Filter Validation.
Key Responsibilities:- Design, author, review, approve, and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
- Design, author, review, approve, and execute execution/development of change controls.
- Resolve technical issues encountered during study execution.
- Engage with Production, Maintenance, and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
- Provide 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.
- Support continuous improvement through Lean Six Sigma methodologies.
- 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, ensuring consideration of the impact on GMP and compliance and decisions made.
- 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.
- Relevant technical qualification(s) in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering qualification, with a 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.
Relevant technical qualification(s) in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering qualification, with a proven track record in delivering excellence.
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