Quality Assurance Compliance Specialist

3 months ago

London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

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 inspectionreadiness 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:

- 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.

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.

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.

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 site’s 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 compl

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