Pharmacy Quality Assurance Manager

Job summary

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Main duties of the job

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About us

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Job description

Job responsibilities

Pharmacy Quality Assurance Manager

We have an exciting opportunity for a experienced Quality Assurance Manager to join our Pharmacy department based at The London Clinic in Central London, with a competitive salary range on offer.

Established in 1932, The London Clinic is one of the UK's largest private hospitals, with state-of-the-art facilities located around Harley Street. We have approx. 1300 employees across 8 sites, where we cover a broad range of specialisms, including complex medical and surgical procedures and a comprehensive range of cancer and outpatient services.

The London Clinic has a supportive and warm working culture where your contribution is valued, and you can help us provide the best, personalised healthcare.

Job Profile

• Development, coordination and management of the pharmacy quality management system (PQS) of the Pharmacy Aseptic Services Unit (ASU) in line with professional and regulatory requirements.

• To work closely with Deputy Chief Pharmacist - Cancer Services, Senior Pharmacists, technical leads and other external service providers / contractors, to develop and maintain the aseptic service provision, and Good Manufacturing Practice (GMP) regulatory requirements for unlicensed activity.
• Responsible for the provision of technical support and advice on medicines quality / quality assurance matters to all areas of Pharmacy and other key stakeholders.
• Assist the management of the Pharmacy Department Medicines Wholesale Dealing Service with the Responsible Person (RP), as per Good Distribution Practice (GDP) regulatory requirements for licensed activity.
• Maintain key relationships with other multidisciplinary teams across the organisation including nursing and medical staff, allied health care professionals, support workers, administration and clerical staff, estates department, service and maintenance contractors, regional and national networks, and patients.
• Participate in working groups and governance committees pertinent to the safe delivery of medicines provision.

• Job Type : This is a full-time, permanent position,

• Shifts : Monday to Friday

• Benefits package:
• Contributory pension scheme (total annual contribution up to 20%).
• Private Medical Healthcare.
• 33 day's annual leave (Inclusive of bank holidays).
• Season ticket travel loan, family friendly benefits, and a wide range of discounts with a variety of retailers/services, plus much more.
• We also offer excellent career development; with clear career pathways and access to further education.

Key Duties Quality Assurance

• To lead and maintain systems based on quality assurance requirements for GMP activities under the Medicines Act 1968 Section 10 exemption for unlicensed activity and for GDP activities under the MHRA WDA(H) licence.
• Ensure efficient day-to-day running of the aseptic services unit with appropriate use of resources.
• Organise appropriate allocation of technical staffing resources to ensure prioritisation of workload and maintained Good Manufacturing Practice.
• Develop and maintain systems to ensure compliance with the guidelines and regulation surrounding the use of cytotoxic and other systemic anti-cancer therapy.
• Develop and maintain systems to ensure appropriate documentation.
• Participate and contribute towards preparation for external auditing regarding compliance with current Good Manufacturing Practice.
• Ensure appropriate documentation, investigation and response to all out of specification exception reports to ensure high standard of Good Manufacturing Practice. Use of Corrective and Preventative Action planning required for exception reporting.

Key Results Areas

• To promote and support the development and implementation of evidence based practice for all staff.
• To develop policies, procedures, guidelines to support the Quality Management System
• To promote and maintain effective communication and disseminate information related to practice development.
• To facilitate acquisition of the necessary skills, knowledge and competency by staff within the aseptic services unit.

Skills & Experience

• Relevant degree OR Pharmacy Qualification
• Substantial Experience as a QA practitioner in Pharmacy manufacturing/aseptic services/technical services under MHRA License.
• Up to date knowledge of national guidelines and legislation (Medicines Act/COSHH/GMP/Health and Safety)
• Please see job description attached for further duties and skills and experience required.

We are an organisation that has charitable status and this helps us to drive forward our mission of reinvesting our income to deliver better patient outcomes.

The London Clinic is proud of its diverse workforce and is committed to building a team that represents a variety of backgrounds, perspectives, and skills.

We absolutely welcome applicants from underrepresented groups; if you think you have the skills and experience for the job, please apply - we would love to hear from you regardless of your background.

Job description

Job responsibilities

Pharmacy Quality Assurance Manager

We have an exciting opportunity for a experienced Quality Assurance Manager to join our Pharmacy department based at The London Clinic in Central London, with a competitive salary range on offer.

Established in 1932, The London Clinic is one of the UK's largest private hospitals, with state-of-the-art facilities located around Harley Street. We have approx. 1300 employees across 8 sites, where we cover a broad range of specialisms, including complex medical and surgical procedures and a comprehensive range of cancer and outpatient services.

The London Clinic has a supportive and warm working culture where your contribution is valued, and you can help us provide the best, personalised healthcare.

Job Profile

• Development, coordination and management of the pharmacy quality management system (PQS) of the Pharmacy Aseptic Services Unit (ASU) in line with professional and regulatory requirements.

• To work closely with Deputy Chief Pharmacist - Cancer Services, Senior Pharmacists, technical leads and other external service providers / contractors, to develop and maintain the aseptic service provision, and Good Manufacturing Practice (GMP) regulatory requirements for unlicensed activity.
• Responsible for the provision of technical support and advice on medicines quality / quality assurance matters to all areas of Pharmacy and other key stakeholders.
• Assist the management of the Pharmacy Department Medicines Wholesale Dealing Service with the Responsible Person (RP), as per Good Distribution Practice (GDP) regulatory requirements for licensed activity.
• Maintain key relationships with other multidisciplinary teams across the organisation including nursing and medical staff, allied health care professionals, support workers, administration and clerical staff, estates department, service and maintenance contractors, regional and national networks, and patients.
• Participate in working groups and governance committees pertinent to the safe delivery of medicines provision.

• Job Type : This is a full-time, permanent position,

• Shifts : Monday to Friday

• Benefits package:
• Contributory pension scheme (total annual contribution up to 20%).
• Private Medical Healthcare.
• 33 day's annual leave (Inclusive of bank holidays).
• Season ticket travel loan, family friendly benefits, and a wide range of discounts with a variety of retailers/services, plus much more.
• We also offer excellent career development; with clear career pathways and access to further education.

Key Duties Quality Assurance

• To lead and maintain systems based on quality assurance requirements for GMP activities under the Medicines Act 1968 Section 10 exemption for unlicensed activity and for GDP activities under the MHRA WDA(H) licence.
• Ensure efficient day-to-day running of the aseptic services unit with appropriate use of resources.
• Organise appropriate allocation of technical staffing resources to ensure prioritisation of workload and maintained Good Manufacturing Practice.
• Develop and maintain systems to ensure compliance with the guidelines and regulation surrounding the use of cytotoxic and other systemic anti-cancer therapy.
• Develop and maintain systems to ensure appropriate documentation.
• Participate and contribute towards preparation for external auditing regarding compliance with current Good Manufacturing Practice.
• Ensure appropriate documentation, investigation and response to all out of specification exception reports to ensure high standard of Good Manufacturing Practice. Use of Corrective and Preventative Action planning required for exception reporting.

Key Results Areas

• To promote and support the development and implementation of evidence based practice for all staff.
• To develop policies, procedures, guidelines to support the Quality Management System
• To promote and maintain effective communication and disseminate information related to practice development.
• To facilitate acquisition of the necessary skills, knowledge and competency by staff within the aseptic services unit.

Skills & Experience

• Relevant degree OR Pharmacy Qualification
• Substantial Experience as a QA practitioner in Pharmacy manufacturing/aseptic services/technical services under MHRA License.
• Up to date knowledge of national guidelines and legislation (Medicines Act/COSHH/GMP/Health and Safety)
• Please see job description attached for further duties and skills and experience required.

We are an organisation that has charitable status and this helps us to drive forward our mission of reinvesting our income to deliver better patient outcomes.

The London Clinic is proud of its diverse workforce and is committed to building a team that represents a variety of backgrounds, perspectives, and skills.

We absolutely welcome applicants from underrepresented groups; if you think you have the skills and experience for the job, please apply - we would love to hear from you regardless of your background.

Person Specification

Qualifications

Essential

• please see job description attached...

Desirable

• please see job description attached...

Experience

Essential

• please see job description attached...

Desirable

• please see job description attached...

Person Specification

Qualifications

Essential

• please see job description attached...

Desirable

• please see job description attached...

Experience

Essential

• please see job description attached...

Desirable

• please see job description attached...

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.

Employer details

Employer name

The London Clinic

Address

22 Devonshire Place

City of London

W1G 6BW



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