Pharmaceutical Validation Expert

Job Title : Pharmaceutical Validation Professional

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• Sterilisation – Autoclaves, SIP of vessels
• Cleaning – Parts Washer and CIP of vessels
• Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation systems
• Controlled Temperature Units (CTU) – Temperature / Humidity Mapping
• Filter Validation

Responsibilities : Our company is looking for an experienced professional to support several aspects of validation. The successful candidate will design, author, review, approve and execute qualification / validation documentation and cycle development studies in line with the standard approval process.

Key responsibilities include : Designing and executing validation plans and protocols; Conducting equipment qualification and performance qualification activities; Resolving technical issues encountered during study execution; Engaging with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities; Authoring / reviewing / approving investigations and quality notifications; Performing root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues; Supporting continuous improvement through Lean Six Sigma methodologies; Serving as validation representative for cross functional projects and representing the validation team at global technical forums; Driving 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; Supporting regulatory audits and submissions as required; Working collaboratively to drive a safe and compliant culture in site.

Qualifications and Skills : Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification; Knowledge of CTU equipment qualification; Knowledge of thermal mapping equipment; 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 analyse 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 orientated manner;

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