Validation Officer
Main Duties and Responsibilities:
* Support CSV needs within units to ensure quality assurance of clinical research programs.
* Deliver expertise and lead on all validation processes, including CSV processes and process validation, for imaging and analysis software, image transfer systems, Electronic Data Capture (EDC) systems and software, randomisation software, electronic document management systems, study management systems, and aspects of data validation.
* Lead and coordinate multiple validation and qualification activities with various research units and external vendors, taking a risk-based approach to validation.
* Create user requirements specifications, technical specifications, and validation reports in accordance with regulatory requirements.
* Maintain validation processes within the quality system, collaborating with QA personnel to ensure studies are conducted in accordance with Good Clinical Practice (GCP) standards, national and international legislation, and meet the quality needs of unit personnel.
* Adhere to GCP, ISO, GDPR, and all associated regulatory, ethical, and legislative requirements in executing the research program.
* Coordinate and deliver mandatory Computer System validation training for unit staff, including CSV training as required.
* Monitor the validated state of all systems that require validation and work with the Quality Manager to ensure they are validated and maintained in a validated state, according to SOPs.
* Manage the CSV change control process and controlled software installation and updates relating to clinical research in associated units.
* Manage the validation of functional aspects of systems, such as installation, database connection, etc.
* Contribute to the implementation and oversight of security protection for associated systems.
* Develop, review, and approve computer system policies and procedures, ensuring compliance with cGMP's, lab policies and procedures, and regulatory requirements (21 CFR Part 11, Annex 11).
* Implement continuous improvement to associated processes as required.
* Contribute to associated procurement activities as required.
* Support regulatory inspections and internal audits.
* Contribute to the investigation of non-conformances and implementation of corrective and preventative actions.
Essential Requirements:
* Bachelor's degree in a scientific, engineering, or healthcare field or equivalent experience.
* Minimum of 4 years' experience working within a regulated quality management system in a similar or related role, working under a quality system framework, and ideally with computer systems validation associated activities.
* Extensive knowledge of validation deliverables associated with each step of the computer system life cycle, including FDA and European compliance regulations, and GAMP guidelines applicable to computer system validation.
* The role requires a candidate who can lead and work autonomously on process development and implementation and management, as well as being a strong team player.
* Experience in delivering training.
* Excellent oral and written communication skills.
* Excellent organizational and interpersonal skills.
Desirable Requirements:
* Experience working in quality assurance, risk management, audit, and/or regulatory inspection.
* Knowledge of Clinical Data Management systems (CDMS) and related software, e.g., iDataFax, RedCap, CASTOR.
* Project Management skills.
* Knowledge of clinical research practices and standards.
* ICH-GCP and/or ISO Training.