Job summary
The post holder will provide ongoing, effective specialist support to the Regulatory Affairs Manager and shall work with the Quality Assurance & Regulatory Compliance Team to support the delivery of the quality system throughout all departments of the Welsh Blood Service (WBS).
They will be responsible for monitoring the systems in place to ensure the organisation continues to meet the appropriate legislative and regulatory requirements for a UK Blood Establishment.
The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.
Main duties of the job
Using specialist knowledge to continuously monitor and determine compliance with regulatory requirements.
Assisting the delivery and coordination of projects pertaining to regulatory governance, with particular focus on regulatory changes affecting the collection, processing, storage, and supply of substances of human origin, including relevant CoE Good Practice Guidelines, UK Medical Devices Regulations, ISO15189, ISO17043 and the associated audit/regulatory inspection of compliance to these regulations and standards.
Acting as an expert resource to support the planning, implementation, and continuous improvement of the WBS quality and regulatory frameworks, processes, and procedures.
Recommend and follow up on initiatives that support the continuous improvement of the WBS Quality Management System (QMS) and regulatory frameworks.
This post is available on a fixed term/secondment basis for 13 months for funding reasons. If applying on a secondment basis, you must obtain permission from your line manager prior to application.
About us
Here at Velindre University NHS Trust we are extremely proud of the specialist services we provide across the whole of Wales in our cutting-edge Velindre Cancer Centre and ouraward-winning Welsh Blood Service, as well as the expertise of our corporate functions that bring the two divisions together. We are also fortunate to host the NHS Wales Shared Services Partnership and Health Technology Wales and have developed strong partnership working with these expert services.
Formed in 1999, the Trust has a dedicated workforce that continuously strives to provide the key principles of prudent healthcare through a wide array of roles. We play a vital role in the communities we support and have ambitious plans for the future to continue to improve the services we deliver. We strive to maintain our core values in everything we do by being; accountable, bold, caring and dynamic, and ensuring the best possible care for our patients and donors.
If you want to work for an organisation that prides itself on making a real difference and offers exciting career opportunities then Velindre University NHS Trust is the place for you.
Visit our website to find out more https://velindre.nhs.wales/
Job description
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac
Please see detailed job description/duties attached.
Full details of role and responsibility are attached.
For further information about this role please contact Martin John, Regulatory Affairs Manager via email: martin.john@wales.nhs.uk or telephone 01443 622000, ext. 2127
Job description
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac
Please see detailed job description/duties attached.
Full details of role and responsibility are attached.
For further information about this role please contact Martin John, Regulatory Affairs Manager via email: martin.john@wales.nhs.uk or telephone 01443 622000, ext. 2127
Person Specification
Qualifications and Knowledge
Essential
- Educated to degree level or have equivalent work experience within a Blood Establishment, pharmaceutical or other safety critical industry, and have knowledge and understanding of: oBlood Establishment QMS or QMS experience in the pharmaceutical, medical device industries or other health care industries/institutions
- oBlood Safety & Quality Regulations, Human Tissue Act, relevant Council of Europe Good Practice Guidelines, and the principles of Good Manufacturing Practice (GMP).
- oRelevant international standards, regulations, and guidelines (e.g., UK Medicines and Medical Device Regulations, EU MDR/IVDR, Clinical Trial Regulations, ISO Standards such as 13485, 15189, 17043, 9001)
Desirable
- Working towards a post-graduate qualification in Regulatory Affairs or a Quality Management discipline.
- Knowledge of Pharmaceutical Product Development Lifecycles
- Evidence of Continuing Professional Development (CPD).
- Registered Member of a Professional Scientific, Pharmaceutical or Engineering Institution/ Organisation
- Member of TOPRA
- Knowledge of GDPR Regulations
- Six Sigma Yellow/Green Belt
Skills and Attributes
Essential
- Excellent oral, written, cross functional and interpersonal communication skills.
- Good presentation skills
- Able to work independently and as part of a team showing good inter-personal and information transfer skills.
- Possesses a systems-thinking and continuous improvement mind-set.
- Analytical and problem-solving approach
- Project and results oriented.
- Versatile with Microsoft Office (Word, Excel, Power-point).
- Maintains confidentiality.
- Professional integrity is essential for this role.
Desirable
- A knowledge of the role of the Welsh Blood Service.
- A positive attitude to change.
- Contributes to innovative ideas and improved ways of working.
- Looks beyond boundaries of own job to support others.
- Demonstrates sound work ethics.
Other
Desirable
- Welsh Speaker (Level 1) or willingness to work towards
Experience
Essential
- Statistical Analysis
- Gap Analysis Techniques
- Root Cause Analysis Techniques
- Creating Standard Operating Procedures
- Internal Auditing
- Formal Risk Management Techniques (e.g., FMEA, FTA, SWOT)
- Lean Principles
- Verification and Validation (including IQ, OQ and PQ)
Person Specification
Qualifications and Knowledge
Essential
- Educated to degree level or have equivalent work experience within a Blood Establishment, pharmaceutical or other safety critical industry, and have knowledge and understanding of: oBlood Establishment QMS or QMS experience in the pharmaceutical, medical device industries or other health care industries/institutions
- oBlood Safety & Quality Regulations, Human Tissue Act, relevant Council of Europe Good Practice Guidelines, and the principles of Good Manufacturing Practice (GMP).
- oRelevant international standards, regulations, and guidelines (e.g., UK Medicines and Medical Device Regulations, EU MDR/IVDR, Clinical Trial Regulations, ISO Standards such as 13485, 15189, 17043, 9001)
Desirable
- Working towards a post-graduate qualification in Regulatory Affairs or a Quality Management discipline.
- Knowledge of Pharmaceutical Product Development Lifecycles
- Evidence of Continuing Professional Development (CPD).
- Registered Member of a Professional Scientific, Pharmaceutical or Engineering Institution/ Organisation
- Member of TOPRA
- Knowledge of GDPR Regulations
- Six Sigma Yellow/Green Belt
Skills and Attributes
Essential
- Excellent oral, written, cross functional and interpersonal communication skills.
- Good presentation skills
- Able to work independently and as part of a team showing good inter-personal and information transfer skills.
- Possesses a systems-thinking and continuous improvement mind-set.
- Analytical and problem-solving approach
- Project and results oriented.
- Versatile with Microsoft Office (Word, Excel, Power-point).
- Maintains confidentiality.
- Professional integrity is essential for this role.
Desirable
- A knowledge of the role of the Welsh Blood Service.
- A positive attitude to change.
- Contributes to innovative ideas and improved ways of working.
- Looks beyond boundaries of own job to support others.
- Demonstrates sound work ethics.
Other
Desirable
- Welsh Speaker (Level 1) or willingness to work towards
Experience
Essential
- Statistical Analysis
- Gap Analysis Techniques
- Root Cause Analysis Techniques
- Creating Standard Operating Procedures
- Internal Auditing
- Formal Risk Management Techniques (e.g., FMEA, FTA, SWOT)
- Lean Principles
- Verification and Validation (including IQ, OQ and PQ)
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).
