An exciting opportunity for an experienced Validation interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation.
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
Supporting regulatory audits and submissions as required.
Equipment Periodic Validation
Equipment Validation Lifecycle
Project Management Skills/Qualification
Filter Validation & Container Closure Validation
Autoclave/SIP Sterilisation Validation
Dry Heat Sterilisation
Vial and Syringe Processing Technologies
For a confidential discussion and more information on the role, please contact Kevin Griffin