Job summary
Are you a Pharmacist, Pharmacy Technician, Healthcare Scientist or Scientist working in Pharmacy or Pharmaceutical Quality Assurance?
We have a fantastic opportunity to join our department as Pharmacy Quality Assurance (QA) Lead based within our Pharmacy Aseptic Services Team.
Our QA Lead will provide a comprehensive quality assurance service to the Pharmacy Department at Torbay Hospital to support aseptic services, radiopharmacy, clinical trials, procurement and all other pharmacy activities
They will support the implementation and ongoing development of effective Pharmaceutical Quality Systems (PQS) throughout the department to ensure continuous improvement of all aspects of the service, and to enhance patient safety
The Quality Assurance service supports our Aseptic and Radiopharmacy departments which operate under Section 10 exemption providing high risk injectables to our patients including systemic anti-cancer treatments, parenteral nutrition, radiopharmaceuticals and other aseptic items.
Main duties of the job
Lead, manage and develop the Pharmacy Quality Assurance service and support the implementation and ongoing development of effective Pharmaceutical Quality Systems (PQS) and compliance with Good Manufacturing Practice (GMP).
Ensure that all Quality Assurance (QA) activity is effectively managed to meet agreed Trust and Pharmacy Department objectives whilst complying with relevant local and national legislation, regulations and guidelines, particularly in relation to current GMP and Good Clinical Practice (GCP)Be responsible for the environmental monitoring program within the unit(s), and the management of the in-house environmental laboratory facilityProvide specialist interpretation of environmental monitoring results, advice and reports to the Accountable Pharmacist for Aseptic Services and RadiopharmacyKeep updated on all standards and guidelines relevant to the work of the pharmacy department. Interpret the standards and guidelines and ensure that all protocols and SOPs meet with current requirementsAct as the line manager and manage the activities of the Quality Assurance Assistant Technical OfficerCo-ordinate the provision of analytical and environmental monitoring services from the Regional Quality Control Laboratory, and other external agencies as required
About us
Our friendly forward thinking Pharmacy team provides procurement, distribution, dispensary, ward-based clinical, cancer, aseptic and homecare services to Torbay Hospital and other community health services.
The Pharmacy Aseptic Services department currently provides approximately 13,000 chemotherapy doses, 200 aseptic items and 1,000 parenteral nutrition bags per annum.
Why work with us
Job description
Job responsibilities
Relevant Science Degree or Masters Degree in Pharmacy orNVQ Level 3 in Pharmacy Services and BTec inPharmaceutical Science or equivalent qualification withextensive experience in QA/QC field
Extensive specialist knowledge of pharmaceutical qualityassurance and analysis
Familiar with laboratory and environmental monitoringequipment
Frequently required to concentrate for long periods on complex tasks or information
For a more detailed job description and main responsibilities please refer to the job description attached to this vacancy.
Job description
Job responsibilities
Relevant Science Degree or Masters Degree in Pharmacy orNVQ Level 3 in Pharmacy Services and BTec inPharmaceutical Science or equivalent qualification withextensive experience in QA/QC field
Extensive specialist knowledge of pharmaceutical qualityassurance and analysis
Familiar with laboratory and environmental monitoringequipment
Frequently required to concentrate for long periods on complex tasks or information
For a more detailed job description and main responsibilities please refer to the job description attached to this vacancy.
Person Specification
Qualifications and Training
Essential
- Relevant Science Degree or Masters Degree in Pharmacy or NVQ Level 3 in Pharmacy Services and BTec in Pharmaceutical Science or equivalent qualification with extensive experience in QA/QC field
- Registered or eligible to register with appropriate professional body
- Postgraduate qualification e.g. MSc in Pharmaceutical Technology and Quality Assurance or equivalent training/experience
- Management training or equivalent experience
Desirable
- Management Qualification or equivalent relevant experience
- COSHH Risk assessor
Knowledge and Experience
Essential
- Extensive specialist knowledge of pharmaceutical quality assurance and analysis
- Knowledge and understanding of systems for quality management and quality improvement
- Excellent knowledge and understanding of current Good Manufacturing Practice (GMP) requirements and other relevant guidance on quality assurance
- Knowledge and understanding of audit and improvement activities in a pharmaceutical environment
- Knowledge of the theory of aseptic technique and understanding of implications.
- Proven record of working in a quality system meeting GMP requirements
- Project management experience, including involvement of multi-disciplinary teams
Desirable
- Knowledge of configuration and use of Ideagen Quality Management Software (formerly Q-Pulse)
Specific Skills
Essential
- Excellent communication, organisational and interpersonal skills
- Self-motivated and able to motivate others
- Awareness of good laboratory practice and good manufacturing practice
- Well-developed IT skills and knowledge of electronic quality management systems e.g. Ideagen Quality Management Software and other IT applications including database programs
- Familiar with laboratory and environmental monitoring equipment
- Understanding of environmental monitoring techniques and data interpretation
Person Specification
Qualifications and Training
Essential
- Relevant Science Degree or Masters Degree in Pharmacy or NVQ Level 3 in Pharmacy Services and BTec in Pharmaceutical Science or equivalent qualification with extensive experience in QA/QC field
- Registered or eligible to register with appropriate professional body
- Postgraduate qualification e.g. MSc in Pharmaceutical Technology and Quality Assurance or equivalent training/experience
- Management training or equivalent experience
Desirable
- Management Qualification or equivalent relevant experience
- COSHH Risk assessor
Knowledge and Experience
Essential
- Extensive specialist knowledge of pharmaceutical quality assurance and analysis
- Knowledge and understanding of systems for quality management and quality improvement
- Excellent knowledge and understanding of current Good Manufacturing Practice (GMP) requirements and other relevant guidance on quality assurance
- Knowledge and understanding of audit and improvement activities in a pharmaceutical environment
- Knowledge of the theory of aseptic technique and understanding of implications.
- Proven record of working in a quality system meeting GMP requirements
- Project management experience, including involvement of multi-disciplinary teams
Desirable
- Knowledge of configuration and use of Ideagen Quality Management Software (formerly Q-Pulse)
Specific Skills
Essential
- Excellent communication, organisational and interpersonal skills
- Self-motivated and able to motivate others
- Awareness of good laboratory practice and good manufacturing practice
- Well-developed IT skills and knowledge of electronic quality management systems e.g. Ideagen Quality Management Software and other IT applications including database programs
- Familiar with laboratory and environmental monitoring equipment
- Understanding of environmental monitoring techniques and data interpretation
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).
