Job summary
An exciting opportunity has arisen for a motivated individual to join our friendly and dynamic team to provide a high quality of Quality Assurance (QA) work for pharmacy technical services.
If you are passionate about quality assurance in pharmaceutical healthcare, we invite you to apply.
You will be part of an expanding QA team dedicated to delivering an excellent, patient-focused service. We are seeking a QA professional to support our MS licenced aseptic manufacturing unit in maintaining compliance with MHRA and other regulatory standards, ensuring the highest quality of pharmaceutical products.
The ideal candidate will embody our Trust values - being empowered, compassionate, professional and inclusive, with a strong understanding of Good Manufacturing Practice (GMP) and the ability to develop safe systems of work and innovative QA processes.
Joining our team offers a chance to impact patient safety and product integrity in a collaborative environment.
You will play a crucial role in validating processes, training staff, and participating in audits.
Main duties of the job
To apply the principles of current Good Manufacturing Practice (GMP) and provide QA support to the QA Lead and the Pharmacy Technical/Cancer services team.
Assist the QA Lead in the day-to-day operations of the Quality Assurance department.
Organise and ensure the Pharmacy Technical Services team carries out the weekly and monthly environmental monitoring programme according to an agreed schedule.
Ensure the staff validation programme for Pharmacy Technical Services and QA is conducted as scheduled.
Maintain and calibrate Pharmacy Technical Services and QA equipment and facilities.
Contribute to the strategic development of the Quality Assurance department, ensuring high service provision and quality standards.Assist in reviewing GMP-controlled documents and Standard Operating Procedures (SOPs).
Assist in reviewing GMP-controlled documents and Standard Operating Procedures (SOPs).
Coordinate responses to drug recalls and safety notifications and manage the safe storage and archiving of GMP documentation.
About us
With a new hospital planned for Watford and work underway to update theatres at St Albans City Hospital, this is an exciting time to join us.
We are building on the success of our award-winning virtual hospital and re-imaging models of care, working ever more closely with partners and making the most of advances in digital healthcare.
Staff wellbeing and development are a priority at our Trust, as is the role of innovation in improving clinical care, outcomes and patient experience.
Our vision is Excellent patient care, together and our values are to be empowered, compassionate, professional and inclusive. They capture an important balance across what we must all do as individuals and to support others.
At West Herts we offer a variety of flexible working options as we recognise the importance of a good work life balance and the ability to work flexibly. https://www.westhertshospitals.nhs.uk/flexibleworking/
We kindly invite you to consider submitting an application.
If you have a disability or long-term health condition and should you require support or guidance please contact westherts.recruitment@nhs.net.
If you are a Service Leaver, Veteran, Military Reserve, Cadet Force Adult Volunteer, or partner/spouse of those serving please tick "Member of the Armed Forces Community" on the application form.
If you do not hear back within 3 weeks of your application, please assume you have been unsuccessful on this occasion.
Job description
Job responsibilities
Please refer to the attached job description and person specification for a full list of duties and details about the role.
Please complete your application form in full, outlining and providing examples of how you meet each of the essential and desirable criteria.
Core hours are Monday to Friday 37.5 hours per week.
The succesful candidate will be required to participate in weekend, Bank Holidays and other departmental rotas, if applicable.
Job description
Job responsibilities
Please refer to the attached job description and person specification for a full list of duties and details about the role.
Please complete your application form in full, outlining and providing examples of how you meet each of the essential and desirable criteria.
Core hours are Monday to Friday 37.5 hours per week.
The succesful candidate will be required to participate in weekend, Bank Holidays and other departmental rotas, if applicable.
Person Specification
Education and qualifications:
Essential
- NVQ 3 or BTEC in Pharmaceutical Sciences, Degree or equivalent.
- Science Manufacturing Technician Apprenticeship Level 3.
- Registered with the GPhC or relevant professional body.
Desirable
- Accredited Checking Qualification.
- Evidence of further post qualification training in Technical Services.
- Up to date CPD portfolio.
Knowledge:
Essential
- Demonstrated understanding of the principles of GMP and QA in Aseptics/Production manufacturing environment.
- Demonstrated understanding of Pharmaceutical Quality Systems.
- Knowledge of Audit and validation.
- Demonstrated understanding of the importance of hygiene standards in the preparation of medicines.
- Computer and IT competent.
- COSHH Regulations and Health and Safety at Work Act.
- Need for confidentiality.
Desirable
- Relevant ISO standards.
- Electronic temperature monitoring systems (Kelsius) BD Cato aseptic workflow system.
- Annex 1 requirements.
Experience:
Essential
- Proven experience of working in Quality Assurance.
- Proven experience of working in a GMP / GLP environment.
- Previous experience of physical and microbiological Environmental Monitoring.
- Proven experience of delivering training.
Desirable
- Writing reports.
- Staff supervision, training and performance appraisal experience.
- Experience of implementing change.
- Developing training packages.
- Advanced use of e-mail, internet, MS Windows, MS Word, MS Excel, MS PowerPoint.
Person Specification
Education and qualifications:
Essential
- NVQ 3 or BTEC in Pharmaceutical Sciences, Degree or equivalent.
- Science Manufacturing Technician Apprenticeship Level 3.
- Registered with the GPhC or relevant professional body.
Desirable
- Accredited Checking Qualification.
- Evidence of further post qualification training in Technical Services.
- Up to date CPD portfolio.
Knowledge:
Essential
- Demonstrated understanding of the principles of GMP and QA in Aseptics/Production manufacturing environment.
- Demonstrated understanding of Pharmaceutical Quality Systems.
- Knowledge of Audit and validation.
- Demonstrated understanding of the importance of hygiene standards in the preparation of medicines.
- Computer and IT competent.
- COSHH Regulations and Health and Safety at Work Act.
- Need for confidentiality.
Desirable
- Relevant ISO standards.
- Electronic temperature monitoring systems (Kelsius) BD Cato aseptic workflow system.
- Annex 1 requirements.
Experience:
Essential
- Proven experience of working in Quality Assurance.
- Proven experience of working in a GMP / GLP environment.
- Previous experience of physical and microbiological Environmental Monitoring.
- Proven experience of delivering training.
Desirable
- Writing reports.
- Staff supervision, training and performance appraisal experience.
- Experience of implementing change.
- Developing training packages.
- Advanced use of e-mail, internet, MS Windows, MS Word, MS Excel, MS PowerPoint.
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).
