Validation Officer
The award-winning educational institute seeks a Validation Officer on a 12-month contract to lead Computer System Validation (CSV) and process validation processes for clinical research. Reporting to Unit Directors, this role requires collaboration with Quality Managers, Programme Managers, Data Management teams, and Clinical Operations Leads.
Main Duties and Responsibilities:
* Support CSV needs within units under directorship to ensure quality assurance of clinical research programmes.
* Deliver expertise on all validation processes, including CSV, for units, ensuring compliance with regulatory requirements.
* Lead multiple validation and qualification activities, taking a risk-based approach.
* Create user requirements specifications, technical specifications, and validation reports according to regulatory standards.
* Maintain validation processes within the quality system to ensure Good Clinical Practice (GCP) standards are met.
* Adhere to GCP, ISO, GDPR, and associated regulatory requirements.
* Coordinate mandatory CSV training for unit staff.
* Monitor validated systems and collaborate with Quality Managers to maintain validated states.
* Manage CSV change control and software updates.
* Validate functional aspects of systems, manage security protection, and develop policies and procedures.
* Implement continuous improvement and contribute to procurement activities.
* Support regulatory inspections and internal audits.
Essential Requirements:
* Bachelor's degree in a scientific, engineering, or healthcare field, or equivalent experience.
* Minimum 4 years' experience in regulated quality management systems in a similar role.
* Extensive knowledge of validation deliverables, FDA, European compliance regulations, and GAMP guidelines.
* Strong leadership and team player skills, excellent communication and organizational skills.
Desirable Requirements:
* Experience in quality assurance, risk management, audit, and/or regulatory inspection.
* Knowledge of Clinical Data Management systems and related software.
* Project Management skills and ICH-GCP and/or ISO Training.