- Quality Management System
- Document Control
- Quality
- Assurance
- Patient Safety
- As part of the Quality team, you will be responsible for the administration of tasks across a range of areas, including:
- CAPA Management, Complaints, Deviations, Change Control, Documentation, Quality Metrics, Risk Management, Audit and Inspection, Supplier Assurance, Pharmacovigilance, Information Governance, Data Integrity, and Validation.
- You will be responsible for the shared quality inbox to support and resolve internal and external quality queries.
- You will contribute to the writing, review, and accuracy checking of SOPs and regulated documents across the organisation.
- You will support in ensuring quality projects and quality assigned actions are delivered in accordance with agreed timeframes.
- To actively manage timescales applied to quality improvement actions and Corrective and Preventative Actions (CAPAs).
- Build and maintain awareness of the QMS requirements throughout the business.
- You will provide administration support for the Quality Management System (QMS) including organisation and facilitation of Quality Risk Management (QRM) Review Meetings.
- You will act as a Pharmaxo values champion and lead on ensuring a patient safety and regulatory compliance culture exists across the operation.
- You will undertake continuing professional development and attend any suitable training and update courses as required.
- You will complete duties delegated by the Senior Management Team.
- You will create and prepare reports for quality metrics.
- Manage the update process and control of documents e.g. SOPs, forms, logs, and patient information leaflets to ensure all documents are reviewed regularly in line with Pharmaxo documentation control processes.
- Develop and manage document management systems, both electronic and hard copy records.
- Perform quality checks on documents to ensure they are accurate, concise, and fit for purpose.
- Create master document templates and forms, when required.
- Be responsible for ensuring document accuracy as part of change management.
- You will ensure alignment between documented processes, training materials and staff practice through auditing and compliance monitoring activities.
- Collaborate with the training team to audit training records and ensure record keeping meets our regulatory requirements.
- You will support the delivery of quality sessions to ensure all staff are engaged in the Pharmaxo patient safety culture.
- You will maintain training competency documents and records to ensure training is aligned with current practices.
- You will produce data reports and metrics on training and competency compliance to Department Managers and provide support and coaching to improve standards.
- You will perform internal self-inspection and audit processes to ensure compliance with GPhC, Care Regulators and GXP standards.
- To proactively manage compliance using tools including self-inspection, quality review and regulatory gap analysis.
- You will support the Information Governance Team in delivery of mandatory training and ensuring robust processes are in place.
- Report on supplier management processes compliance including routine supplier and customer checks, customer approvals and non-conformance.
- To triage and manage all Adverse Drug Event reports to ensure compliance with agreed timelines.
- To support tasks relating to Pharmacovigilance requirements including, but not limited to, Source Data Verification and reconciliation tasks.
- To ensure quality oversight of all patient safety activity and provide coaching to staff.
- To ensure key performance indicators for PV activities are monitored and met.
- Ensure all operational service complaints and incidents are appropriately managed, responded to and closed in line with the Homecare Standards.
- To support in the investigation and response of service complaints alongside the Patient Services Team.
- To ensure key performance indicators for all complaints and incidents activities are monitored and met.
- To work collaboratively with the Clinical Governance lead to identify trends and themes to improve patient safety.
- Competitive salary
- Annual leave of 25 days + bank holidays (increasing to 27 days after 3 years' service)
- Annual company bonus scheme (subject to scheme eligibility)
- Pension - you will be auto-enrolled after 3 months of employment at 5% (with an employer contribution of 4%). You can also opt to increase your contribution to 6% to which the employer will contribute 8%.
- Life assurance 10 x salary with a max of £300,000
- Access to Employee Assistance Programme, counselling service and virtual GP service
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Quality Coordinator - Corsham, United Kingdom - Pharmaxo
6 days ago
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Description
Quality Coordinator
About us
The Pharmaxo Group is an award winning, market leading pharmaceutical and healthcare business that serves customers, patients and medical professionals across the UK.
We are located in a modern manufacturing and office facility in Corsham Science Park in Wiltshire, just 5 miles from Chippenham and 8 miles from Bath. The Pharmaxo Group comprises of:
Bath ASU which produces thousands of aseptically (sterile) compounded injectable pharmaceutical products each day for hospitals and patients who are fighting cancer, living with chronic disease or in need of pain relief.
Pharmaxo Healthcare which is a growing clinical homecare provider in an expanding market offering greater convenience to patients whilst delivering efficiencies to the NHS.
Pharmaxo Scientific which develops the innovations in biotechnology, data and information technology that drive our businesses.
Your role at Pharmaxo Healthcare
You will be responsible for working across the Pharmaxo business to support the organisation in achieving regulatory compliance and delivering a culture with patient safety at its core.
You will be a key part of the quality team performing quality tasks across a range of regulatory areas. This is an ideal opportunity for an entrance level role to learn and develop skills in quality management. Our Quality Coordinators work collaboratively and are assigned areas of responsibility within the following areas:
You will be required to have exceptional attention to detail and be integral in delivering a learning culture to ensure patient safety is maintained.
Your duties & responsibilities
Quality Management System:
Document Control:
Quality Assurance
Patient Safety
This job description is not intended to be exhaustive. The post holder may be required to be flexible and take on projects and responsibilities as the company grows.
Full job description can be found here:
Benefits
Apply for this job Share this job Closing Date12/06/2024
LocationCorsham
DepartmentQuality
Job TitleQuality Coordinator
Salary£23,871 per annum
ExperiencePrevious experience of homecare or comparable patient caring services
CityCorsham
CountryUnited Kingdom