Data Integrity and Computer Systems Validation

4 weeks ago

London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

A hard working and enthusiastic individual, ideally with hands on experience in undertaking validation work both protocol generation and review of system compliance.

Previous experience in training in CSV and DI is essential for the role.

**Computerised Systems Process Owner**: Is the owner of the business processes being managed. The Process Owner is responsible for ensuring that the computerised system and its operation is in compliance and fit for intended use in accordance with industry legislation, guidance, and applicable PMU SOPs. The Process Owner is responsible for the data residing in the system and is therefore ultimately responsible for the integrity of the data.

**A Validation Specialist**: Is responsible for ensuring the GSTT PMU validation policies and procedures, including validation document templates, are efficient and compliant. Is responsible for the processes of selection, purchasing, and introduction of new GxP systems into routine use within the PMU. The role also includes remediation work for existing GxP systems (both laboratory and manufacturing) in cases where system configurations require improvement/optimisation, validation, revision/improvement of procedures, and retraining of users.

Reporting to the head of pharmaceutical lifecycle, you will lead and be overall responsible for the site compliance to all aspects of computer system validation and data integrity.

Provide specialist advice and recommend actions to Pharmacy manufacturing units for the ongoing maintenance of regulatory compliance.

Guy's and St Thomas' Pharmacy Technical Services is one of the largest NHS pharmacy technical departments in the country and employs over 120 staff across multiple manufacturing and preparation areas. Our large on-site QA team provides support and guidance to all units providing technical services working under our MS, MIA(IMP) and WDA licences, as well as to units providing unlicensed 'Section 10' preparation services.

Refer to job description for full details and responsibilities

GXP Systems Maintenance
- Responsible for completion of initial DIRA (Data Integrity Risk Assessment) of any new GxP system being proposed for introduction.
- Responsible for performing Periodic Reviews and undertaking risk-monitoring via completion of DIRA (Data Integrity Risk Assessment) of current GxP systems to ensure continued compliance and audit-readiness.
- Manage GxP equipment/systems documentation to ensure documents provide true representations of the installed and operational systems.
- Provide feedback and support to GMP areas in scope during process improvement, while ensuring compliance with current policies and standards
- Manage the computerised systems lifecycle documentation to ensure systems comply with data lifecycle requirements from initial data creation/recording to archive and decommissioning. Reviewing backup/restore, data management, data security, electronic signatures, electronic records, Batch Records and Audit Trails.
- Act as the point-of-contact for vendors with respect to management of GxP equipment/systems annual re-calibrations/re-qualifications, servicing and preventative maintenance, and firmware/software updates.

GxP Systems
- Data Integrity and Validation Remediation
- Undertake investigations of equipment/systems to identify any compliance and/or workflow efficiency shortfalls.
- Complete DIRA (Data Integrity Risk Assessment) and Mitigation Reports as required.
- Optimise computerised system configurations (optimised for efficient workflow and data integrity). Document the configurations in CST (Configuration Statement) documents. Consultation with SMEs is required to ensure configurations are acceptable to the system users.
- Validate the optimised system configurations via CSV (Computerised System Validation) testing.
- Update/write new procedures to reflect the new system configurations.
- Retrain system users as required.
- In cases where a system cannot be brought into compliance due to lack of appropriate system functionality or unsupported software and/or hardware, replace the system using the optimised GxP systems introduction workflow.
- To prepare and contribute along with providing support to other PMU teams as a DI / CSV SME any medical equipment bids or new software / hardware non-standard request bids / forms to obtain compliant hardware and software on an ongoing basis.
- To forecast and plan in for future rolling replacement of systems with the relevant teams to ensure ongoing compliance with regulatory expectations.

Quality Management System Validation
- To author where appropriate, validation documentation for computerised systems. To include (but not limited to) URS, IQ, OQ, PQ, Validation Plans and VSRs,
- To coordinate with appropriate units testing of computerised systems such as UAT.
- To own and be responsible for writing where required and maintaining the policies and procedures associated with GxP systems introduction and maintenance, i

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