Job summary
We are looking for an experienced data integrity and computer systems validation specialist to join our pharmaceutical lifecycle management team, part of the site QA team. The successful candidate will have experience in working in the field of pharmaceuticals and be an expert in all ALCOA+ principles both in enacting and assessing compliance.
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.
Main duties of the job
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.
About us
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.
Job description
Job responsibilities
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, including validation.
- To review and approve procedures and protocols prepared for the introduction and ongoing use of GxP systems.
- Responsible for refining the policies and procedures associated with GxP systems introduction, including validation. The GxP systems introduction and validation workflows are currently under review as a part of continuous-improvement project work. The workflows will be refined and made ready for GxP systems remediation work.
Vendor Management
- Contact equipment/system vendors to gather information about equipment/system functionality for optimisation of system configurations and for the completion of DQ (for new/replacement systems).
Manage introductions of new GxP Equipment/Systems
- Responsible for the hands-on management of new GxP equipment/systems introductions according to the relevant PMU policies and procedures.
Act as Data Steward
- Provide recommendations of opportunities for increased data integrity and efficiencies in operational improvements.
Act and Data Integrity and Validation SME
- Provide the business GMP functions any updates regarding data integrity/validation regulations that they may be impacted by.
- The role will require entry to the manufacturing and production areas to gather data about the production equipment/systems. This will be in line with all HSE PPE requirements and appropriate training. Access to equipment will predominantly be during equipment downtime.
- The role will require entry to the Quality Control Laboratories. This will be in line with all HSE PPE requirements and appropriate training.
Job description
Job responsibilities
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, including validation.
- To review and approve procedures and protocols prepared for the introduction and ongoing use of GxP systems.
- Responsible for refining the policies and procedures associated with GxP systems introduction, including validation. The GxP systems introduction and validation workflows are currently under review as a part of continuous-improvement project work. The workflows will be refined and made ready for GxP systems remediation work.
Vendor Management
- Contact equipment/system vendors to gather information about equipment/system functionality for optimisation of system configurations and for the completion of DQ (for new/replacement systems).
Manage introductions of new GxP Equipment/Systems
- Responsible for the hands-on management of new GxP equipment/systems introductions according to the relevant PMU policies and procedures.
Act as Data Steward
- Provide recommendations of opportunities for increased data integrity and efficiencies in operational improvements.
Act and Data Integrity and Validation SME
- Provide the business GMP functions any updates regarding data integrity/validation regulations that they may be impacted by.
- The role will require entry to the manufacturing and production areas to gather data about the production equipment/systems. This will be in line with all HSE PPE requirements and appropriate training. Access to equipment will predominantly be during equipment downtime.
- The role will require entry to the Quality Control Laboratories. This will be in line with all HSE PPE requirements and appropriate training.
Person Specification
Knowledge/Qualifications
Essential
- Batchelor of Science degree in maths, engineering, computer science or related scientific discipline or extensive experience to equivalent level working in a data integrity or validation role
Desirable
- Project Management qualification such as Prince2
Experience
Essential
- Significant GMP, Quality, and Data Integrity knowledge (several years experience).
- Experience with hands-on Validation, including CSV (Computerised Systems Validation).
- Managing projects or teams of people. Can be small-scale.
- Specific quality and compliance expertise in sterile dose forms and /or functional expertise in validation
- Demonstrated ability to manage, lead and motivate a team.
- Previous evaluated experience of delivering induction and competency-based training
- Demonstrated experience of ability to appraise staff and set performance objectives.
Desirable
- Held previous positions as Project Lead/Manager
- Experience working with pharmaceutical manufacturing equipment, including electronic control systems (PLC, SCADA, HMI, Manufacturing Vessels, Filling and Packing lines)
- Hands on experience in pharmaceutical quality assurance and compliance, manufacturing and/or development, working with a broad range of pharmaceutical dosage forms.
- Quality and compliance expertise with non-sterile and sterile dosage forms
Skills
Essential
- Full understanding of GAMP5, PIC/S Data Management Guidance, EudraLex Volume 4, Annexes 11 and 15, and FDA 21CFR part 11.
- Full understanding of the ALCOA+ principles and their application to both electronic and paper data.
- Detail oriented, capable of following instructions precisely, and capable of accurately transcribing detailed information
- Demonstrated understanding of current regulations governing Specials manufacture and the role of the MHRA
Desirable
- Able to work in a methodical and organized fashion and maintain mental focus to ensure efficient and accurate completion of individual tasks.
Person Specification
Knowledge/Qualifications
Essential
- Batchelor of Science degree in maths, engineering, computer science or related scientific discipline or extensive experience to equivalent level working in a data integrity or validation role
Desirable
- Project Management qualification such as Prince2
Experience
Essential
- Significant GMP, Quality, and Data Integrity knowledge (several years experience).
- Experience with hands-on Validation, including CSV (Computerised Systems Validation).
- Managing projects or teams of people. Can be small-scale.
- Specific quality and compliance expertise in sterile dose forms and /or functional expertise in validation
- Demonstrated ability to manage, lead and motivate a team.
- Previous evaluated experience of delivering induction and competency-based training
- Demonstrated experience of ability to appraise staff and set performance objectives.
Desirable
- Held previous positions as Project Lead/Manager
- Experience working with pharmaceutical manufacturing equipment, including electronic control systems (PLC, SCADA, HMI, Manufacturing Vessels, Filling and Packing lines)
- Hands on experience in pharmaceutical quality assurance and compliance, manufacturing and/or development, working with a broad range of pharmaceutical dosage forms.
- Quality and compliance expertise with non-sterile and sterile dosage forms
Skills
Essential
- Full understanding of GAMP5, PIC/S Data Management Guidance, EudraLex Volume 4, Annexes 11 and 15, and FDA 21CFR part 11.
- Full understanding of the ALCOA+ principles and their application to both electronic and paper data.
- Detail oriented, capable of following instructions precisely, and capable of accurately transcribing detailed information
- Demonstrated understanding of current regulations governing Specials manufacture and the role of the MHRA
Desirable
- Able to work in a methodical and organized fashion and maintain mental focus to ensure efficient and accurate completion of individual tasks.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
