Job summary
The Quality Assurance Compliance Specialist will work with and support a diverse, innovative team to implement and maintain effective QMS processes and compliance across the site, providing assurance that quality product is manufactured, tested, and released to patients.
The team leads the QMS processes to maintain a state of inspection readiness including the management of key quality processes.
Experience with MHRA and Home Office inspection along with a strong foundation in core QA processes, principles and attention to detail are key for this role.
You will manage and maintain Quality System processes and associated documentation to ensure compliance with Regulatory Standards and department expectations. This includes but is not limited to the following quality systems:
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- Complaint Management
- Product Quality Reports
- Document Control
- Internal & External Audit
- QMS performance i.e. KPI's, monthly and quarterly reports.
You will issue and control CGMP documentation to support site activity.
You will support continuous improvement of quality documentation and processes to ensure compliance with CGMP.
You will deliver CGMP and Quality Systems training in line with Site requirements.
You will carry out internal and external audits in line with plan. To act as lead auditor, to identify, action and close out all non-compliance issues with adherence to schedule.
You will maintain and update information on latest Regulatory standards for use by the site.
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 routine regulatory and client audits such as the MHRA, Home Office, EL(97)52 and CT sponsors.
Providing 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.
Reporting to the Head 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.
Provide specialist advice and recommend actions to Pharmacy manufacturing units and other QA team members on compliance PQS metrics and PQS support.
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
Refer to Job Description for full details
Regulatory
- Act as a Quality Subject Matter Expert (QSME) during MHRA Regulatory Inspections and NHS Quality Audits.
- To lead and manage the response to regulatory audits coordinating the raising of actions and RFI requests in collaboration with the Head of Pharmaceutical Quality.
- To ensure any reports resulting from metric reviews, inspections or audit responses are generated in a timely manner.
- To prepare, submit and track any variations submitted for the site MIA(IMP) and MS licences.
- To oversee the completion of the annual home office returns and renewal of the Home Office Controlled Drugs Licence.
- To support the maintenance of the site WDA and assist the RP with QMS management.
PQS Management
- To be responsible for the sites quality complaints program ensuring timely acknowledgement of customer complaints and appropriate logging in the QMS
- Support with Review and approval of Compliance documents e.g. Deviations, Action / Status forms and CAPAs.
- Prepare and track compliance metrics for all PQS items and open inspection / audit findings to ensure timely completion.
- Support Quarantine and Recall activities including ensuring the appropriate recall paperwork has been completed and tracking any communication and response with regulatory authorities such as the MHRA DMRC.
- Prepare a product quality review template and undertake the compilation of reports for the MS lines prepared by the site.
- Support the completion of product quality reviews by other relevant unit specialists for MS lines prepared by the site.
- To review sites compliance to capacity plans in accordance with regulatory expectations as part of ongoing review of compliance metrics.
- Coordination of and participation in the monthly and quarterly Quality Management & Review meetings, compiling the associated compliance metrics for presentation and discussion with the Head of Pharmaceutical Quality and Manufacturing Unit leads along with the site Senior Leadership Team. Preparation of the associated minutes and raising and tracking to completion any associated actions arising from the meeting.
- To provision / coordinate the updating of existing Quality Procedures in conjunction with the Deputy QA manager and Head of Pharmaceutical Quality.
- Review / lead Process investigations / Risk Assessment Documents and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
Job description
Job responsibilities
Refer to Job Description for full details
Regulatory
- Act as a Quality Subject Matter Expert (QSME) during MHRA Regulatory Inspections and NHS Quality Audits.
- To lead and manage the response to regulatory audits coordinating the raising of actions and RFI requests in collaboration with the Head of Pharmaceutical Quality.
- To ensure any reports resulting from metric reviews, inspections or audit responses are generated in a timely manner.
- To prepare, submit and track any variations submitted for the site MIA(IMP) and MS licences.
- To oversee the completion of the annual home office returns and renewal of the Home Office Controlled Drugs Licence.
- To support the maintenance of the site WDA and assist the RP with QMS management.
PQS Management
- To be responsible for the sites quality complaints program ensuring timely acknowledgement of customer complaints and appropriate logging in the QMS
- Support with Review and approval of Compliance documents e.g. Deviations, Action / Status forms and CAPAs.
- Prepare and track compliance metrics for all PQS items and open inspection / audit findings to ensure timely completion.
- Support Quarantine and Recall activities including ensuring the appropriate recall paperwork has been completed and tracking any communication and response with regulatory authorities such as the MHRA DMRC.
- Prepare a product quality review template and undertake the compilation of reports for the MS lines prepared by the site.
- Support the completion of product quality reviews by other relevant unit specialists for MS lines prepared by the site.
- To review sites compliance to capacity plans in accordance with regulatory expectations as part of ongoing review of compliance metrics.
- Coordination of and participation in the monthly and quarterly Quality Management & Review meetings, compiling the associated compliance metrics for presentation and discussion with the Head of Pharmaceutical Quality and Manufacturing Unit leads along with the site Senior Leadership Team. Preparation of the associated minutes and raising and tracking to completion any associated actions arising from the meeting.
- To provision / coordinate the updating of existing Quality Procedures in conjunction with the Deputy QA manager and Head of Pharmaceutical Quality.
- Review / lead Process investigations / Risk Assessment Documents and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
Person Specification
Qualifications
Essential
- Relevant Science based degree e.g. chemistry, biology or related scientific discipline
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 e.g. PTQA PGDip / QP QMS modules completed
Experience
Essential
- A strong understanding of cGMP & basic QMS e.g. deviations, change control, SOPs.
- Previous, relevant pharmaceutical experience.
Desirable
- Previous evaluated experience of QA involvement in the management of clinical trials according to GMP and GCP.
- Previous evaluated experience of developing and expanding QA services
- Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits
- Previous experience of using computerised systems for QMS data input and trending including reporting and trend analysis
Skills
Essential
- Well organised, proactive with a dynamic approach to problem solving, challenging assignments & working to critical timelines
- Demonstrated ability to identify and manage risks.
- Demonstrated ability to undertake the day to day management, motivation and appraisal of staff.
Desirable
- Demonstrated ability to apply specialist knowledge of GMP, GCP & Quality Assurance to ensure a safe and effective service provision.
Person Specification
Qualifications
Essential
- Relevant Science based degree e.g. chemistry, biology or related scientific discipline
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 e.g. PTQA PGDip / QP QMS modules completed
Experience
Essential
- A strong understanding of cGMP & basic QMS e.g. deviations, change control, SOPs.
- Previous, relevant pharmaceutical experience.
Desirable
- Previous evaluated experience of QA involvement in the management of clinical trials according to GMP and GCP.
- Previous evaluated experience of developing and expanding QA services
- Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits
- Previous experience of using computerised systems for QMS data input and trending including reporting and trend analysis
Skills
Essential
- Well organised, proactive with a dynamic approach to problem solving, challenging assignments & working to critical timelines
- Demonstrated ability to identify and manage risks.
- Demonstrated ability to undertake the day to day management, motivation and appraisal of staff.
Desirable
- Demonstrated ability to apply specialist knowledge of GMP, GCP & Quality Assurance to ensure a safe and effective service provision.
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).
