Job summary
*Advert will close early once sufficient volume of applications is reached*
The purpose of the role is to support the Head of QMS and Validation (Quality Manager) in the development, implementation and management of the Pharmaceutical Quality System in accordance with current Good Manufacturing Practice.
The post holder will work collaboratively with all members of the team including supervising the Quality Technicians and acting as Duty Quality Assessor.
Provide support within the laboratory by participating in the Duty Manager rota, when required.
Main duties of the job
In the absence of the Quality Manager, chair the Laboratory Quality Meeting and present reports to Section Heads on quality and operational key performance indicators.
Deliver specialist training in quality management and good manufacturing practices to laboratory staff and customers whose background may not be quality management.
In the absence of the Quality Manager, to act as a deputy, in order to provide advice and guidance in relation to the laboratory pharmaceutical quality system.
When required, act as chair for the laboratory quality meetings and represent the laboratory at MHRA audits of customer facilities.
To supervise the Quality Technicians including performance of appraisals and one to ones.
Assist with performance of internal audits of the laboratory service to ensure compliance with the requirements of the pharmaceutical quality system, GMP and relevant standards and to produce reports to outline audit findings.
Assess the effectiveness of the pharmaceutical quality system and in conjunction with the other members of the Quality Department, implement changes as required.
To understand and implement quality management principles which will include investigating deviations and developing procedures and controlled documents.
About us
At North Tees & Hartlepool NHS Foundation Trust our main priority is, and always will be, to provide safe and high quality care to our patients every day; the kind of care we would want for ourselves and our loved ones. We want our organisation to be the best place to work with the right staff, in the right roles, at the right time, to ensure we deliver exceptional patient care and experience.
We are an Active Hospital and strongly encourage participation of all staff and patients. We expect MECC for all our people interactions.
We will support staff through providing an inclusive and supportive workplace with health and well-being initiatives, staff benefits and opportunities for personal and professional development. Staff recognition is very important to us; as well as performance reviews and appraisals, we recognise staff through Star and Team of the month, colleague recognition - a note of thanks, Managers Awards, Shining Stars and Service Awards.
We recruit for values and "Together we are North Tees & Hartlepool"
Job description
Job responsibilities
To report directly to the Head of QMS & Validation (Quality Manager) on issues relating to quality management within the laboratory
The post holder will be required to communicate with other Quality Control Staff and clients unfamiliar with quality management principles
To assist with undertaking external audits of suppliers of goods and services to the laboratory to ensure quality management principles are maintained.
To lead, as necessary, and take part in audits of the laboratory by external bodies such as the MHRA and customers. Introduction and validation of updated or new cost effective quality management processes.
Job description
Job responsibilities
To report directly to the Head of QMS & Validation (Quality Manager) on issues relating to quality management within the laboratory
The post holder will be required to communicate with other Quality Control Staff and clients unfamiliar with quality management principles
To assist with undertaking external audits of suppliers of goods and services to the laboratory to ensure quality management principles are maintained.
To lead, as necessary, and take part in audits of the laboratory by external bodies such as the MHRA and customers. Introduction and validation of updated or new cost effective quality management processes.
Person Specification
Qualifications
Essential
- oDegree or equivalent level of qualification in a relevant subject
Desirable
- Qualification relevant to Quality management
Experience
Essential
- oExperience within a GMP inspected laboratory, understanding of cGMP and current pharmaceutical quality management
- oExperience of performing root cause analysis
- oExperience supervising staff
Desirable
- Knowledge of Pharmaceutical Quality Control processes
Experience
Desirable
- Experience of auditing a laboratory
Skills
Essential
Approach
Essential
- oAbility to communicate effectively to a range of people with conflicting priorities oAbility to train others oAbility to influence others
Person Specification
Qualifications
Essential
- oDegree or equivalent level of qualification in a relevant subject
Desirable
- Qualification relevant to Quality management
Experience
Essential
- oExperience within a GMP inspected laboratory, understanding of cGMP and current pharmaceutical quality management
- oExperience of performing root cause analysis
- oExperience supervising staff
Desirable
- Knowledge of Pharmaceutical Quality Control processes
Experience
Desirable
- Experience of auditing a laboratory
Skills
Essential
Approach
Essential
- oAbility to communicate effectively to a range of people with conflicting priorities oAbility to train others oAbility to influence others
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).
Employer details
Employer name
North Tees & Hartlepool NHS Foundation Trust
Address
University Hospital of North Tees
Hardwick Road
Stockton-on-Tees
TS19 8PE
Employer's website
https://www.nth.nhs.uk/ (Opens in a new tab)
