Important Job Application Information
Thank you for your interest in NHS Tayside vacancies.
Please see below Job Description/Specification and General Conditions of Service.
Your Application Form must be completed in full. Please note copies of Curriculum Vitae,
Qualifications and Course Certificates will not be accepted at this stage.
Please return your completed Application Form to recruitment.tayside@nhs.net (quoting the
vacancy reference number in the subject box) or to the postal address given on the General
Conditions of Service.
All completed applications are held in Human Resources until the closing date. After the closing
date a panel will meet to prepare an interview shortlist. Once this decision has been made, all
shortlisted applicants will be emailed to invite them to attend for interview. It is important that you
check your emails regularly, including your spam/junk box.
This process takes approximately 6 weeks. Therefore, if you have not been contacted regarding
interview within 6 weeks of the closing date, your application has been unsuccessful and you will
receive no further correspondence from Human Resources.
ADDITIONAL INFORMATION:Find out more about living and working in Tayside at:
www.dundeecity.gov.uk
www.angus.gov.uk
www.pkc.gov.uk
NHS TAYSIDE – AGENDA FOR CHANGE
JOB DESCRIPTION
1. JOB
IDENTIFICATION
Job Title
Specialist Pharmacist, Production
Department(s)/Location
Tayside Pharmaceuticals/NHS
Scotland Pharmaceutical ‘Specials’
Service
Number of job
holders
Three
2.




JOB PURPOSE
Assists with the day to day management of Production sections within TP/NHSS PSS
including staff management
Delegated responsibility for the sourcing of appropriate raw materials and associated
documentation
Gives technical advice internally and to customers
Develops, audits, supervises and takes part in the production of medicines that are not
commercially available
3. ORGANISATIONAL POSITION
See Appendix 1- Organisational Chart
4. SCOPE AND RANGE

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
Manages a team of technicians and ATO’s and takes part in the management of the
department when required
Responsible for ensuring the principles of Good Pharmaceutical Manufacturing Practice
(GMP) and other legislation are followed within Production
Reports problems to Production Manager and Quality Assurance Manager
Participates in new product development including process method
The Sterile Production department produces a range of 250 sterile medicines; selling 273,000
units annually with a value of £1.2 million.
The majority of products are produced by heat sterilisation. This involves:
 weighing materials
 changing and entering clean rooms
 mixing solutions and making up to volume
 setting up filling equipment with filters
 sealing containers
 sterilising containers in autoclaves
 inspecting, labelling and packaging finished product
products manufactured include:
 epidural packs
 eye drops
 injections in ampoules
 intravenous infusions
 irrigation solutions
 clinical trial material
For those products that cannot be heat sterilised, aseptic production takes place in a specially
maintained filling room. Care is required during manipulations not to introduce bacterial and
particulate contamination. Aseptic production involves:
 pre-sterilisation of components and clothing
 weighing materials




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mixing and making to volume
sterile clothing change technique and entry into the filling room
sterilisation by filtration or by sterile transfer processes that can involve the use of syringes,
pressurised vessels and peristaltic pumps
the rest of the process is the same as sterilisation by heat
products manufactured include
 antibiotic vials docked with diluent
 parenteral nutrition solutions
 clinical trial material
The Non-sterile Production section produces a range of 700 medicines; selling 750,000 units
annually with a value of £2.1million.
Products manufactured include:
 ointments and creams
 repackaged and overlabelled tablets, capsules and liquids
 manufactured internal and external liquids
 emergency drug boxes for hospital, community and the Scottish Ambulance Service
 clinical trials materials, including manufactured active and placebo capsules
Typical production of non-sterile medicines involves:
 weighing materials
 changing and entering production rooms
 mixing solutions and making up to volume
 setting up filling equipment
 filling and sealing containers
 inspecting, labelling and packaging finished products
5. MAIN DUTIES/RESPONSIBILITIES
Main duties 90% of time:
Responsible for participating in the training of Specialist Pharmacy Technicians. The post
holder takes part, when required, in the training of other Technicians and ATO’s, ensuring the
safe and effective operation of approved procedures and compliance with GMP




ensuring that the Production department operates in compliance with the standards of GMP
assisting the Production Manager with Production Scheduling and Materials Requirements
Planning (MRP)
responsible for sourcing raw materials of appropriate quality and for obtaining the required
regulatory documentation
responsible for new product development including process method (for example finding
the correct pH of a solution so it does not crystallise on heating) and preparing the Master
Worksheet and Label for approval. This may also involve performing a trial run of the
product before passing on for routine production
Participate in Clinical Trials activities within Tayside Pharmaceuticals including:
 assessing TP’s capability to undertake the work
 liaison with customers to define the specification and provide a quotation
 creation of a Product Specification File
 planning the randomisation and manufacture of the of Clinical Trial material
 tracking the progress of the manufacture throughout Production, QA, Sales Office and
Store to ensure customer deadlines are met
 on-going communication with customer during the period of the Clinical Trial
 interpretation and conversion of aseptic intravenous feeding prescriptions into a product
formula, and ensuring stability of the product
 giving advice on formulation and stability of parenteral nutrition solutions to customers
 auditing of sterilisation records
 auditing of autoclave validations
 responsible for ensuring the maintenance of plant and equipment including:
 distillation plant
 autoclaves
 Rota ampoule machine
 Plumat bag filling machine
 responsible for monitoring Planned Preventative Maintenance of plant and equipment by
estates staff
 formulating and revising Standard Operating Procedures, Master Worksheets and Labels.
Planning document review for the departmental technicians
 problem solving, dealing with equipment breakdown and autoclave failures
 control and dispensing of Controlled Drug products and raw materials
 cover the work of the Pharmacy Technicians and ATO’s when staff shortages require,
including:

final checking of products before submission to Quality Assurance. This involves
judgement skills, used to analyse the accuracy of worksheet entries and sterilisation
records

check operational conditions of facility and decides if production should start

loading of autoclaves and checking charts, involves pushing heavy trolleys
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
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manufacture of products requiring technical skills such as clinical trials materials
accurate entry of data into worksheets, charts and logs
organise routine ordering, stock control and record keeping
responsible for production planning and allocation of work
Other duties 10% of time:
 auditing of operators aseptic technique
 responsible for training of Student Pharmacists
 planning and randomisation of Clinical Trials
 chairing and taking minutes in staff meetings
 Health and Safety risk assessor for Sterile Production. Coordinate the work of other
assessors
 preparing spread sheets and reports for monthly meetings
 undertake Performance Development Reviews for technicians
 participate in managing sickness including back to work interviews
 dealing with customer and staff complaints and queries
 covering for other Specialist Production Pharmacists in their absence
6. COMMUNICATIONS AND RELATIONSHIPS
The postholder will communicate with a wide range of people, both within and without the
organisation including:
 Production Manager, QA Manager and Head of NHSS PSS
 Specialist Production Pharmacists
 staff within all Production teams
 Quality Assurance, Stores and Office staff within TP
 senior professional staff from other NHS Tayside departments - product related issues
 Health & Safety personnel - H&S/COSHH issues within Production
 Estates staff - equipment breakdowns, planned preventative maintenance, validation of
equipment
 Clinical Trials customers - trial design, specifications, licensing issues, manufacture,
randomisation
 customers - product specifications, technical advice, customer complaints, planning of
clinical trials
 outside contractors - GMP issues relating to work being undertaken
In order to communicate effectively with the above groups, the following are essential:

well developed interpersonal and communication skills, written and verbal, formal and
informal

ability to inform, motivate and develop the Production team with regards to service
developments and new initiatives

present detailed information in a variety of formats regarding the service information and
developments in formal and informal settings

presentation skills to present and report on service information and developments in
formal and informal settings

ability to use tact, empathy and diplomacy when dealing with staffing issues and urgent
requests for medicines
7. KNOWLEDGE, TRAINING AND EXPERIENCE REQUIRED TO DO THE JOB
Qualifications – Essential

Master of Pharmacy degree (MPharm)

competency assessed and examined professional registration (MRPharmS) - 1 year

mandatory CPD to maintain fitness to practice
Qualifications – Desirable

specialist higher degree/diploma in Pharmaceutical Technical Services
Experience – Essential
Previous full time equivalent post qualification pharmacy practice experience

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Experience – Desirable
Previous experience of:
licensed pharmaceutical manufacturing operations
participation in the manufacture or preparation of Clinical Trials materials
writing Standard Operating Procedures relating to pharmaceutical manufacture
operating under a quality management system (eg BS EN ISO 9001)
staff management
Knowledge
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technical knowledge of pharmaceutical manufacturing and aseptic services
knowledge of all aspects of GMP and ability to apply this knowledge in practice
formulation of pharmaceutical products to meet clinical needs of patients
ability to apply knowledge in the writing of Standard Operating Procedures
ability to deliver staff training and validation
knowledge of risks associated with handling hazardous materials and appropriate H&S
precautions
8. SYSTEMS AND EQUIPMENT
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Highly complex equipment:
expert knowledge required to set up, operate (if required), calibrate and train staff in the use
of highly complex equipment including:
 autoclaves
 automatic bottle washer
 ampoule filling machine
 parenteral nutrition solution filler
 polypropylene bottle filler
 intravenous infusion bag filler
 peristaltic pumps
 ointment tube filler
 ointment tube sealer
 capsule filling machine
learning how to use the above equipment requires four to eight weeks’ training
learning how diagnose and correct faults with the above equipment takes a minimum of six
months experience (12 months for autoclaves and bottle washer)
Routine equipment:

Expert knowledge required to set up, operate (if required), calibrate and train staff in the
use of routine equipment including:
 electronic weigh scales
 peristaltic pumps
 mixers and sealers
 porous load pack sealer

learning how to use the above equipment requires three to four weeks training

basic keyboard skills and knowledge of standard office software (word processor,
spreadsheets, database) in order to produce standard worksheets and labels, and prepare
reports

operation of Q-Pulse CAPA system software

operation of computerised stock control system

operation of labeling software

use of the internet to source technical information
Systems the post holder will be required to operate / oversee include:

NHS Tayside Health and Safety policies

Departmental Standard Operating Procedures

Performance Development Review

NHS Tayside Data Protection and Information Security Policy

Control of Substances Hazardous to Health (COSHH)
Responsibility for Records Management
All records created in the course of the business of NHS Tayside are corporate records and are
public records under the terms of the Public Records (Scotland) Act 1937. This includes email
messages and other electronic records. It is your responsibility to ensure that you keep appropriate
records of your work in NHS Tayside and manage those records in keeping with the NHS Tayside
Records Management Policy and with any guidance produced by NHS Tayside specific to your
employment.
9. PHYSICAL DEMANDS OF THE JOB
Physical Effort

mainly office based, long periods of VDU use. Regular need to walk between locations
and stand for long periods while performing in-process checks, assisting staff and
troubleshooting processes

occasional need to bend and lift heavy boxes, trays and filling equipment

occasional need to push heavy trolleys and operate pallet lifter

occasional need to push heavy trolleys and to change Oxygen and Nitrogen cylinders.
Mental Effort

operate a computer for prolonged periods while producing standard operating procedures
and worksheets

intense concentration is required for long periods whilst signing off complex worksheets
and autoclave charts

dealing with staff problems and complaints and complaints from internal departments and
customers

dealing with equipment breakdown and resultant problems

calculation skills are required to translate prescriptions and change formulas on worksheets

occasional supervision of ATO’s

the workload is subject to constant interruptions due to staff queries and office requests
Working Conditions
 mainly office based
 use of a computer for prolonged periods
 daily exposure to unpleasant odours from, eg coal tars, alcohols
 occasional requirement to wear non-breathable suits, hoods and masks for up to 2½ hours,
resulting in hot and uncomfortable working conditions
 occasional requirement to sanitise aseptic products using iso-propyl alcohol which is toxic
and involves wearing heavy, uncomfortable organic vapour masks for periods of up to 2½
hours
 hazardous materials are occasionally handled, great care must be taken and protective
clothing worn. These include:
 hot distilled water at 80C
 potent drugs such as Adrenaline and Morphine
 toxic and caustic substances such as Liquefied Phenol and Glacial Acetic Acid
 handling of piped gasses
Physical Skills

manual dexterity and good hand-to-eye co-ordination are required in the assembly and set
up of complex equipment in which the post holder is required to train operators and
develop standard operating procedures

thepost holder is required to train operators in tasks that require specialised manual
dexterity such as sealing ampoules and compounding of complex parenteral nutrition
solutions
ESSENTIAL ADDITIONAL INFORMATION
10. DECISIONS AND JUDGEMENTS
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discretion to make judgements and work within the parameters of Departmental Procedures
refers to Production Manager and Quality Assurance Manager over failures of procedure
participates with QA Manager in resolving out-of-specification results
consequences of discrepancies in autoclave charts and autoclave performance
assesses suitability of staff to undertake production operations
provides input into production planning to ensure customer needs are met
participates in staff recruitment.
11. MOST CHALLENGING/DIFFICULT PARTS OF THE JOB
 Job can be stressful as the postholder is usually the person who resolves immediate failures
in production plant and processes. If no resolution can be found then batches worth
thousands of pounds can be lost. Plant and process failures occur frequently
 Sourcing of the appropriate grade of raw materials which can involve discussions with UK
and world-wide pharmaceutical companies
 Dealing with out of specification products and non-conformances
 Dealing with staff and customer problems and complaints
12. JOB DESCRIPTION AGREEMENT
The job description will need to be signed off using the attached sheet by each postholder to
whom the job description applies.
TAYSIDE PHARMACEUTICALS
Appendix 1
Organisation Chart (April 2015)
NHS Tayside
Director of
Operations
Head of NHSS PSS
Tayside
Pharmaceuticals
PA/Project
Administrator
Principal Pharmacist
Quality Assurance
Validation/Quality
Systems Specialist
Laboratory Manager
Quality Assurance
Senior Technicians
Quality Assurance
ATOs
Quality Assurance
Principal Pharmacist
Production
Specialist
Pharmacists
Quality Assurance
Specialist Pharmacist
Non-Sterile
Production
Specialist Technician
Non-Sterile
Production
Senior Technician
Non-Sterile
Production
ATOs
Specialist Pharmacist
Sterile Production
Specialist Technician
Sterile Production
ATOs
Customer Services
Manager
Specialist Pharmacist
Sterile/NonSterileProduction
Admin & Clerical
Officers
Stores Manager
Storepersons
PERSON SPECIFICATION
POST:
SPECIALIST PHARMACIST - PRODUCTION, BAND 7
DEPARTMENT:
NHS SCOTLAND PHARMACEUTICAL ‘SPECIALS’ SERVICE /
TAYSIDE PHARMACEUTICALS
1 EXPERIENCE
ESSENTIAL
 Previous full time post
qualification pharmacy
practice
DESIRABLE
 Experience in pharmaceutical
manufacturing, aseptic
dispensing or QA
 Training and supervision of
staff
2 QUALIFICATIONS
 Registrant of the General
Pharmaceutical Council and
commitment to CPD
 Specialist higher
degree/diploma in
Pharmaceutical Technology
and Quality Assurance or
equivalent
3 KNOWLEDGE &
SKILLS
 Knowledge and
understanding of GMP and
GCP
 Knowledge of H&S and
COSHH
 Problem solving skills
 Accuracy and attention to
detail
 Technical knowledge of
formulation and
manufacturing
4 PERSONAL
SKILLS
 Effective verbal and written
communications
 Report writing and
presentation skills
 Good organisational skills
 Ability to prioritise own
workload
 Take responsibility for
working practice
 Good timekeeping
5 OTHER
 Tact, empathy and
diplomacy when dealing with
staff
 Ability to work autonomously
 Intense concentration
required for prolonged
periods
 Flexibility
General Conditions of Service
POST REF NO:
D/LR/14A/15
JOB TITLE/GRADE:
SPECIALIST PHARMACIST - PRODUCTION, BAND 7
LOCATION:
NHS SCOTLAND PHARMACEUTICAL ‘SPECIALS’
SERVICE (PSS)
Conditions of Service
Remuneration
Hours of Duty
Superannuation
The terms and conditions of service for this post are those
determined by the NHS Staff Council.
The current salary scale for the post is £31,383 to £41,373 per
annum (pro rata for part-time staff). Placing on the scale on
appointment is normally at the minimum but may be higher
subject to verification of previous relevant service.
Salary is paid monthly by Bank Credit Transfer.
The hours of the post are 37.5 hours per week.
Start and finish times will be determined by the needs of the
service.
Membership of the NHS Superannuation Scheme is not
compulsory but is open to all staff between the ages of 16 and
70 (65 in some instances).
The contributions paid are a percentage of superannuable pay,
which is essentially basic pay excluding, for example, overtime
or travelling expenses.
Contribution rates with effect from 01.04.14 are as follows:
Annual Pensionable Pay
(Full-time equivalent)
Up to £15,431
£15,432 to £21,387
£21,388 to £26,823
£26,824 to £49,472
£49,473 to £70,630
£70,631 to £111,376
£111,377 and over
Annual Leave
Contribution
5%
5.6%
7.1%
9.3%
12.5%
13.5%
14.5%
Contributions are subject to tax relief and reduced National
Insurance contributions. NHS Tayside also makes a substantial
contribution towards scheme benefits – currently around 14% of
basic pay.
On appointment = 27 days (pro rata for part-time Staff) or 5.4
weeks per year.
After 5 years aggregated service = 29 days (pro rata for part-time
staff) or 5.8 weeks per year
After 10 years aggregated service = 33 days (pro rata for part-
time staff) or 6.6 weeks per year
References
Public Holidays = 8 days (pro rata for part-time staff) or 1.6
weeks per year
All offers of appointment are subject to receipt of two satisfactory
references.
Occupational Health
Clearance
All offers of appointment to new entrants to the National Health
Service are subject to a medical examination. Medical
examinations are arranged and undertaken by the Occupational
Health and Safety Advisory Service (OHSAS).
Rehabilitation of
Offenders Act 1974
(Exclusions and
Exceptions) (Scotland)
Order 2003
All current or spent criminal convictions, cautions, warnings or
any case pending must be disclosed prior to commencing in
employment as detailed on the application form.
Disclosure Scotland
Immigration, Asylum and
Nationality Act 2006
Please note that having a conviction will not automatically debar
you from obtaining employment with NHS Tayside. Careful
consideration will be given to the relevance of the offence to the
particular post in question. However, if you are appointed, and it
is found that you did not reveal a previous conviction your
employment may be terminated.
Not required.
It is a criminal offence for an employer to employ anyone who
does not have permission to live or work in the UK.
Shortlisted applicants will be asked to produce specific original
documentation at interview e.g. Passport, or full birth certificate
together with an official document giving the applicants
permanent National Insurance Number and name issued by a
Government Agency or a previous employer, as well as
photocopies of these documents.
Professional Registration/ you should have current and continuing professional registration
Induction Standards &
with GPhC and hold the appropriate qualification(s).
Code of Conduct
Smoking Policy
NHS Tayside operates a No Smoking Policy and smoking
is prohibited within NHS premises and grounds.
Applications
Completed forms should be returned to:
recruitment.tayside@nhs.net quoting the job reference in the
subject line
or
to Human Resources Directorate, NHS Tayside, Level 9,
Ninewells Hospital, Dundee DD1 9SY
By closing date of Friday 20 November 2015
Once this decision has been made, all shortlisted applicants will
be emailed to invite them to attend for interview. It is important
that you check your emails regularly, including your spam/folder
box.