Job summary
Pharmaceutical Quality Assurance Compliance Specialist
We are looking for an excellent and motivated quality professional to join our Quality Team based multisite at Guys and St Thomas'. Ideally you will have experience working in the pharmaceutical industry or NHS in quality assurance.
The successful candidate must have previous specific quality and compliance expertise within the relevant industry and a proven track record of excellence.
Working with us provides excellent opportunities to utilise your GMP and Quality knowledge, skills and experience and prepare you for more senior roles leading on projects and staff management opportunities.
The QA department supports a variety of areas across the hospital trust and there is an opportunity to work with a wide variety of teams across multiple disciplines.
Main duties of the job
The role of Quality Assurance Compliance Specialist is critical to ensuring the sites compliance with GMP and GDP regulatory expectations. The post holder will provide expertise to support the site in the case of regulatory and client audits such as the MHRA, Home Office, EL(97)52 and CT sponsors.
The post holder will be expected to provide routine oversight over all key quality metrics associated with the pharmaceutical quality system and key performance indicators identified by the quality team. Contributing to the overall improvement of the units from a Quality/GMP perspective, with an emphasis on continuous improvement of the quality system.
About us
Guy's and St Thomas' is among the UK's busiest and most successful NHS Foundation Trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopedic, respiratory and cardiovascular services.
Guy's & St Thomas' Technical Services is a large licensed and section 10 manufacturing unit with a wide product portfolio, including terminally sterilised, aseptically manufactured and non-sterile products, as well as a variety of extemporaneously prepared aseptic and non-sterile dosage forms. Pharmacy Technical Services employs over 100 staff in multiple areas across the Guy's and St Thomas' sites.
Pharmacy Quality Assurance provides QA support to a number of facilities across both the Guy's and St Thomas' sites, including the MS licensed Aseptic, Sterile and Non-sterile Units and also unlicensed units (CIVAS/TPN and Oncology) and the main Pharmacy.
Job description
Job responsibilities
Reporting to the Head of Pharmaceutical Quality, you will develop and manage a small team of QA staff, to plan and manage resources, so that the overall objectives of the compliance team can be consistently met and site maintains a state of inspection readiness.
You will be expected to provide specialist advice and recommend actions to Pharmacy Manufacturing Units and other QA team members on compliance PQS metrics and PQS support.
For further duties, please see attached job description.
Job description
Job responsibilities
Reporting to the Head of Pharmaceutical Quality, you will develop and manage a small team of QA staff, to plan and manage resources, so that the overall objectives of the compliance team can be consistently met and site maintains a state of inspection readiness.
You will be expected to provide specialist advice and recommend actions to Pharmacy Manufacturing Units and other QA team members on compliance PQS metrics and PQS support.
For further duties, please see attached job description.
Person Specification
Qualifications
Essential
- Relevant science based degree eg: Chemistry, Biology or related science disicipline
Desirable
- Member of professional society/institution (Royal Society of Chemistry, Royal Society of Biology, Royal Pharmaceutical Society)
- IRCA Lead Auditor Accredited
- Quality assurance related qualification/study eg: PTQA PGDip/QP QMS modules completed
- Formal leadership/managerial training
Experience
Essential
- A strong understanding of cGMP and basic QMS eg: deviations, change controls, SOPs
- Previous relevant pharmaceutical experience
- Specific quality and compliance expertise in quality assurance
- Previous experience of using computerised systems for QMS data input and trending including reporting and trend analysis
- Previous experience of conducting audits and project work
Desirable
- Previous experience in performance or disciplinary reviews and HR management
- Previous evaluated experience of delivering induction and competency-based training
- Previous experience of business planning and service development
- Previous experience of managing budgets
- Previous experience of ability to appraise staff and set performance objectives
Skills
Essential
- Demonstrated understanding of current regulations governing Specials manufacture and the role of the MHRA
- Demonstrated ability to apply specialist knowledge of GMP, GCP and Quality Assurance to ensure a safe and effective service provision
- Demonstrated ability to manage deviations, change control and CAPA as well as perform risk assessments and root cause analysis
- Demonstrated understanding of validation of equipment and processes and experience of ensuring validation plans are adhered to
- Demonstrated ability to critically review GMP documentation and standard operating procedures completed or created by others
Person Specification
Qualifications
Essential
- Relevant science based degree eg: Chemistry, Biology or related science disicipline
Desirable
- Member of professional society/institution (Royal Society of Chemistry, Royal Society of Biology, Royal Pharmaceutical Society)
- IRCA Lead Auditor Accredited
- Quality assurance related qualification/study eg: PTQA PGDip/QP QMS modules completed
- Formal leadership/managerial training
Experience
Essential
- A strong understanding of cGMP and basic QMS eg: deviations, change controls, SOPs
- Previous relevant pharmaceutical experience
- Specific quality and compliance expertise in quality assurance
- Previous experience of using computerised systems for QMS data input and trending including reporting and trend analysis
- Previous experience of conducting audits and project work
Desirable
- Previous experience in performance or disciplinary reviews and HR management
- Previous evaluated experience of delivering induction and competency-based training
- Previous experience of business planning and service development
- Previous experience of managing budgets
- Previous experience of ability to appraise staff and set performance objectives
Skills
Essential
- Demonstrated understanding of current regulations governing Specials manufacture and the role of the MHRA
- Demonstrated ability to apply specialist knowledge of GMP, GCP and Quality Assurance to ensure a safe and effective service provision
- Demonstrated ability to manage deviations, change control and CAPA as well as perform risk assessments and root cause analysis
- Demonstrated understanding of validation of equipment and processes and experience of ensuring validation plans are adhered to
- Demonstrated ability to critically review GMP documentation and standard operating procedures completed or created by 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).
