Job Opportunity:
A Validation Specialist is sought to lead the development of process validation protocols and reports for new product introductions and revalidations.
Key Responsibilities:
* Create and execute process validation protocols and reports, ensuring compliance with industry standards.
* Develop solutions to sustain and improve the Quality Management System (QMS).
* Maintain site change control processes, ensuring changes to validated processes are effectively managed.
* Generate risk assessments covering cleaning, validation, and process.
* Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
* Support Good Manufacturing Practice (GMP) and regulatory audits.
* Prepare training modules as required.
* Analyse data and provide informed decisions and recommendations based on data.
* Support continuous improvement initiatives using Lean Six Sigma methodologies.
* Execute and develop change controls.
* Perform root cause analysis of system failures using standard tools like Failure Mode and Effects Analysis (FMEA), Fishbone diagrams, and 5 Whys.
* Implement corrective actions through the change management system.
Requirements:
* Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
* Experience in statistical analysis, Statistical Process Control (SPC), and validations.
* Excellent interpersonal, communication, influencing, and facilitation skills.
* Prior experience as a Validation Engineer within an injection moulding or medical manufacturing environment is essential.