Validation Officer
My client, an award winning educational institute is looking to recruit a Validation Officer on a 12 month contract. The purpose of this role is to lead the Computer System Validation (CSV) and process validation processes required to conduct clinical research. The role is overseen by the Clinical Trials Institute and Head of Programmes. The post-holder will report directly to the Unit Directors, working closely with the Quality Manager(s), Programme Manager(s), Data Management team and Clinical Operations Lead(s). This opportunity comes with flexible working hours and the option of hybrid/remote working. Flexible working hours and the option for hybrid/remote working in line with the institutions policies are available with this opportunity.
Main Duties and Responsibilities:
- Work with teams under the appropriate directorship to support the Computer System Validation (CSV) needs within the respective units, to support quality assurance of clinical research programmes.
- Deliver expertise and lead on all validation processes for the units including CSV processes and process validation as required. This includes validation of 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., , as they apply to the processes, software, electronic systems and equipment in the associated research programme.
- Lead and coordinate multiple validation and qualification activities with various research units and external vendors taking a risk based approach to validation.
- Lead creation of user requirements specifications, technical specifications and validation reports in accordance with regulatory requirements.
- Maintain validation processes within the quality system in collaboration with QA personnel to ensure that studies carried out are conducted in accordance with Good Clinical Practice (GCP) standards, national and international legislation and meet the quality needs of unit personnel.
- Adherence to the requirements of GCP, ISO 14155, GDPR and all associated regulatory, ethical and legislative requirements in the execution of the research programme.
- Coordinate and deliver mandatory Computer System validation training for unit staff, including CSV training as required.
- Monitoring the validated state of all systems that require validation and working with the Quality Manager to ensure that they are validated, and maintained in a validated state, according to the SOPs.
- Manage the CSV change control process and controlled software installation and updates relating to clinical research in associated units.
- Managing the validation of the functional aspects of the system 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 associated non-conformances and implementation of corrective and preventative actions.
Essential Requirements:
- Bachelor's degree in a scientific, engineering or health care field, or equivalent experience.
- Minimum of 4 years' experience of working within a regulated quality management system in a similar or related role(s) working under a quality system framework and ideally with computer systems validation associated activities. (e.g. medtech, biomedical, pharmaceutical industry.).
- 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 and also someone who is a strong team player.
- Experience in the delivery of 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 eg. idatafax,RedCap, CASTOR.
- Project Management skills.
- Knowledge of clinical research practices and standards.
- ICH-GCP and/or ISO 14155 Training.
For more information, please email [email protected]
