Job summary
An exciting and challenging opportunity has arisen within the Clinical Diagnostics and Therapeutics Clinical Board to join the Quality and Regulatory team.
The post will be based in Pharmacy working within the Quality Assurance team to maintain and develop the Pharmaceutical Quality System across the licensed pharmacy manufacturing sites and unlicensed aseptic preparation units at St Mary's Pharmaceutical Unit (SMPU) and Llandough Aseptic Unit.
We are looking for a highly skilled pharmacy professional or healthcare scientist with significant experience working in a regulated quality assurance or manufacturing GMP environment. A demonstrated knowledge of quality assurance processes that support aseptic, sterile and non-sterile pharmacy manufacturing is desirable however training in specialist areas will be provided.
The post will work alongside a team of pharmacy professionals to meet the quality and compliance demands of this diverse service. The role will provide technical support and advice, conduct audits, complete CAPAs, drive quality improvements as well as supporting the GMP and QC activities and release of product to customers and patients. The post will flex to the needs of the service and provide QA support to other regulated services within the clinical board.
If you are interested in joining a friendly, hardworking and motivated team with an opportunity to learn and utilise a wide range of skills and expertise, come and meet the team!
Main duties of the job
The post will have it's focus directed to Quality Assurance of the aseptic preparation activities at SMPU and Llandough aseptic unit and thelicensed classical manufacturing duties at SMPU.
The role will provide technical support and advice, conduct audits, complete CAPAs, drive qualityimprovements as well as supporting the GMP and QC activities and release of product to customersand patients.
The ability to speak Welsh is desirable for this role; Welsh and/or English speakers are equallywelcome to apply.
NHS Wales Pharmacy Technical services will gradually transition to a centralised Transforming Access to Medicines (TrAMs) service hosted by NHS Wales Shared Services Partnership (NWSSP).
The current service provided by Cardiff & Vale University Health Board and its employees will therefore transfer to NWSSP in line with the transition period.
Please contact the recruiting manager if you wish to discuss this further. More information on the TrAMs programme can be found here: Transforming Access to Medicines - NHS Wales Shared Services Partnership.
About us
Cardiff and Vale University Health Board is one of the largest Integrated Health Boards in the UK, employing over 17,000 staff, providing over 100 specialist services. Working across 6 hospital sites, we have a diverse range of career opportunities to offer. Serving over 500,000 people living in Cardiff and the Vale, we are focussed on the health and care needs of our local population whilst working with our partners to develop regional services. Together we are committed to improving health outcomes for everyone, delivering excellent care and support.
Our mission is "Living Well, Caring Well, Working Together", and our vision is that every person's chance of leading a healthy life should be equal. Our 10-year transformation and improvement strategy, Shaping Our Future Wellbeing, is our chance to work collaboratively with the public and our workforce to make our health board more sustainable for the future.
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.
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.
Person Specification
Qualifications
Essential
- MPharm or MSc pharmacy degree or equivalent.
- Registered with the General Pharmaceutical Council or an appropriate body
- Experience in pharmacy in hospital or commercial sectors.
- Knowledge of relevant Quality Assurance documentation and guidance; Annex 1, PIC/S etc.
- NVQ Level 3 / BTEC in Pharmacy in Pharmacy Services
Desirable
- Post-graduate MSc/Diploma in Clinical Pharmacy or PTQA or relevant experience
- Membership of Royal Pharmaceutical Society of Great Britain
- Management or Supervisory Qualification
- A1 NVQ Assessor Qualification
Experience
Essential
- Minimum 2 years broad Post-Registration experience of working in a hospital pharmacy with knowledge of technical service
- Ability to manipulate, interpret and work with all computer-based programs, applications and documents
- Proven record of change management implementation
- Specialist knowledge of areas of technical services including aseptic preparation, MHRA "Specials" manufacturing.
- Experience in developing, writing, and approving standard operating procedures
Desirable
- Post qualification experience of working in a licensed pharmaceutical facility.
- Experience of participating in regulatory audits such as MHRA inspections as well as DGM (97)52 (now WHC) audits.
- Experience of patient orientated medicines systems.
- Expenditure reporting and provision of clinical board support.
- Supervisory or management experience and Cleanroom supervision
Skills
Essential
- A good working knowledge of the day to day operation of a technical services, its aims and objectives.
- Good verbal/written communication skills.
- Excellent Decision-making and deductive reasoning skills
- Evidence of effective multidisciplinary team working and collaborative approach to technical services.
- Evidence based therapeutics (to support clinical and cost-effective practices)
- Evidence of Legal, ethical and professional framework for accountability and responsibility in relation to prescribing.
- Good knowledge of pharmacology and therapeutics. Evidence-based therapeutic benefits/risks.
- Motivated, logical, adaptable, flexible
- Analytical skills and attention to detail.
- Ability to work as a team and under own initiative
- Positive attitude to change.
- Innovative and well organised.
- Computer literate.
- Aware of (and able to work within) own limitations.
- Manual dexterity to manipulate injections or prepare pharmaceutical products, and good hand-eye co-ordination.
- Strong organisational skills
- Excellent Documentation skills
- Good understanding & knowledge of;Operational pressures and demands of aseptic services, Safe handling prescribing and use of cytotoxic drugs,Cross contamination, Contamination Control Strategies, ATMPs and Gene Therapy, Hydrogen Peroxide and HPV technology.
- GMP, GDP and GxP legislation and guidance
- Demonstrated knowledge and awareness of aseptic unit procedures and systems.
- Ability to process complex information and develop reports/business cases to support findings
- Ability to remain calm when challenged.
Desirable
- Negotiation skills
- Knowledge of economics of healthcare.
- Confident and calm at all times.
- Assertive, Tactful, Persuasive.
- Compassionate and understanding with colleagues
- Ability to deal with varying demands of pharmaceutical facilities, prioritise and eliminate tasks.
- Welsh Language Skills are desirable levels 1 to 5 in understanding, speaking, reading, and writing in Welsh.
Other
Essential
- A commitment to self-study and self-development.
- A commitment to Continuing Education and Continuing Professional Development (CPD).
- Takes ownership and responsibility
- Approachable and professional manner.
- Ability to remain calm in a busy environment.
- Satisfactory standard DBS check
- Ability to travel independently between sites
Desirable
Person Specification
Qualifications
Essential
- MPharm or MSc pharmacy degree or equivalent.
- Registered with the General Pharmaceutical Council or an appropriate body
- Experience in pharmacy in hospital or commercial sectors.
- Knowledge of relevant Quality Assurance documentation and guidance; Annex 1, PIC/S etc.
- NVQ Level 3 / BTEC in Pharmacy in Pharmacy Services
Desirable
- Post-graduate MSc/Diploma in Clinical Pharmacy or PTQA or relevant experience
- Membership of Royal Pharmaceutical Society of Great Britain
- Management or Supervisory Qualification
- A1 NVQ Assessor Qualification
Experience
Essential
- Minimum 2 years broad Post-Registration experience of working in a hospital pharmacy with knowledge of technical service
- Ability to manipulate, interpret and work with all computer-based programs, applications and documents
- Proven record of change management implementation
- Specialist knowledge of areas of technical services including aseptic preparation, MHRA "Specials" manufacturing.
- Experience in developing, writing, and approving standard operating procedures
Desirable
- Post qualification experience of working in a licensed pharmaceutical facility.
- Experience of participating in regulatory audits such as MHRA inspections as well as DGM (97)52 (now WHC) audits.
- Experience of patient orientated medicines systems.
- Expenditure reporting and provision of clinical board support.
- Supervisory or management experience and Cleanroom supervision
Skills
Essential
- A good working knowledge of the day to day operation of a technical services, its aims and objectives.
- Good verbal/written communication skills.
- Excellent Decision-making and deductive reasoning skills
- Evidence of effective multidisciplinary team working and collaborative approach to technical services.
- Evidence based therapeutics (to support clinical and cost-effective practices)
- Evidence of Legal, ethical and professional framework for accountability and responsibility in relation to prescribing.
- Good knowledge of pharmacology and therapeutics. Evidence-based therapeutic benefits/risks.
- Motivated, logical, adaptable, flexible
- Analytical skills and attention to detail.
- Ability to work as a team and under own initiative
- Positive attitude to change.
- Innovative and well organised.
- Computer literate.
- Aware of (and able to work within) own limitations.
- Manual dexterity to manipulate injections or prepare pharmaceutical products, and good hand-eye co-ordination.
- Strong organisational skills
- Excellent Documentation skills
- Good understanding & knowledge of;Operational pressures and demands of aseptic services, Safe handling prescribing and use of cytotoxic drugs,Cross contamination, Contamination Control Strategies, ATMPs and Gene Therapy, Hydrogen Peroxide and HPV technology.
- GMP, GDP and GxP legislation and guidance
- Demonstrated knowledge and awareness of aseptic unit procedures and systems.
- Ability to process complex information and develop reports/business cases to support findings
- Ability to remain calm when challenged.
Desirable
- Negotiation skills
- Knowledge of economics of healthcare.
- Confident and calm at all times.
- Assertive, Tactful, Persuasive.
- Compassionate and understanding with colleagues
- Ability to deal with varying demands of pharmaceutical facilities, prioritise and eliminate tasks.
- Welsh Language Skills are desirable levels 1 to 5 in understanding, speaking, reading, and writing in Welsh.
Other
Essential
- A commitment to self-study and self-development.
- A commitment to Continuing Education and Continuing Professional Development (CPD).
- Takes ownership and responsibility
- Approachable and professional manner.
- Ability to remain calm in a busy environment.
- Satisfactory standard DBS check
- Ability to travel independently between sites
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).
