Job summary
NWSSP Pharmacy Division is recruiting to the position of Head of Quality. The successful candidate will demonstrate extensive GMP knowledge and experience gained through quality assurance roles.
You will be managerially accountable for the staff, service and resources relating to quality assurance activity for the existing production unit ensuring that it meets Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Distribution Practice (GDP) requirements, Health and Safety at Work, Control of Substances Hazardous to Health (COSHH), The Human Medicines Regulations and any other relevant statutory requirements, to deliver a timely, high quality and patient-focused service.
We are currently in the process of developing a radiopharmacy service with a new build unit based at IP5 adjacent to the current production unit. It is our intention to apply for a variation to our current specials licence to include the operation of this new state of the art facility for which the postholder will be responsible. The postholder will have a key role in developing this service and preparing the unit for MHRA licensing.
Main duties of the job
The post holder will be responsible at an operational level for holding the licenses for the unit, which may include Manufacturer's License (Specials) (MS), Manufacturer's License (Investigational Medicinal Products) (MIA IMP), Wholesale Dealing Authorisation (WDA), all governed by the Medicines and Healthcare Products Regulatory Authority (MHRA), and the Controlled Drugs License (Misuse of Drugs Act 1971 and Misuse of Drugs regulations (MDR) 2001 governed by the Home Office.
In collaboration with the Head of Production, the post holder will be responsible for maintaining formal contact with the MHRA inspectors and auditors and putting in place effective corrective and preventative actions (CAPA) in response to their inspection process.
The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply.
About us
At NHS Wales Shared Services Partnership we expect everyone to embrace our values of Listening and Learning, Working Together, Taking Responsibility and Innovating.
Our organisation encourages an agile working approach and we pride ourselves on being a learning organisation motivated by continuous improvement.
We are committed to creating an inclusive workplace that values equality, diversity and inclusion, focussing on the wellbeing and belonging of our people.
Excellent customer service is something we strive for, for both our internal and external customers.
Offering a comprehensive benefits package, there is something for everyone. To find out more about working for us, the benefits we offer and guidance on the application process please visit https://nwssp.nhs.wales/working-for-us/
NWSSP work in an agile way where possible, all posts will have a contractual base but as part of agile ways of working that may mean working from home and other locations. We also look at how we balance flexibility with community, and how to manage opportunities to learn from each other.
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
This post may be included in a forthcoming organisational change process, to create the Transforming Access to Medicines (TrAMs) Service. The nature and timescales of the proposed change will be subject to consultation in conjunction with the All-Wales Organisational Change Policy. There is no anticipated risk to employment due to this change. Please contact the recruiting manager if you wish to discuss this further. More information on the TrAMs programme of change can be accessed on the NHS Wales Shared Services (NWSSP) internet :Transforming Access to Medicines - NHS Wales Shared Services Partnership
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
This post may be included in a forthcoming organisational change process, to create the Transforming Access to Medicines (TrAMs) Service. The nature and timescales of the proposed change will be subject to consultation in conjunction with the All-Wales Organisational Change Policy. There is no anticipated risk to employment due to this change. Please contact the recruiting manager if you wish to discuss this further. More information on the TrAMs programme of change can be accessed on the NHS Wales Shared Services (NWSSP) internet :Transforming Access to Medicines - NHS Wales Shared Services Partnership
Person Specification
Qualifications
Essential
- Master's degree such as Level 7 Pharmaceutical Technology & Quality Assurance (PTQA) (Masters) or Scientist Training Programme (STP)
- Pharmaceutical Science or relevant pharmaceutical knowledge, and specialist and practical experience of GMP systems management acquired over five years (as defined by MHRA guidance) and equivalent to that required for a post-graduate diploma,
- Management or Leadership qualification or accreditation - or demonstrable equivalent experience,
Desirable
- Accredited Product Approver (S10 Medical Act) and Cleanroom Supervision (CRS) accreditation,
- Quality Improvement Accreditation
Experience
Essential
- Relevant post-qualification GMP experience providing NHS Aseptic services or within an MHRA licensed unit
- Experience of Quality Risk Management (QRM) or other comprehensive pharmaceutical quality management system,
- Experience of undertaking risk assessment, root cause analysis and CAPA, change control,
Skills
Essential
- Project management and strong organisational skills
Desirable
Person Specification
Qualifications
Essential
- Master's degree such as Level 7 Pharmaceutical Technology & Quality Assurance (PTQA) (Masters) or Scientist Training Programme (STP)
- Pharmaceutical Science or relevant pharmaceutical knowledge, and specialist and practical experience of GMP systems management acquired over five years (as defined by MHRA guidance) and equivalent to that required for a post-graduate diploma,
- Management or Leadership qualification or accreditation - or demonstrable equivalent experience,
Desirable
- Accredited Product Approver (S10 Medical Act) and Cleanroom Supervision (CRS) accreditation,
- Quality Improvement Accreditation
Experience
Essential
- Relevant post-qualification GMP experience providing NHS Aseptic services or within an MHRA licensed unit
- Experience of Quality Risk Management (QRM) or other comprehensive pharmaceutical quality management system,
- Experience of undertaking risk assessment, root cause analysis and CAPA, change control,
Skills
Essential
- Project management and strong organisational skills
Desirable
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
