Quality Coordinator

1 week ago

Corsham, United Kingdom Qualasept Full time

**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:

- Quality Management System
- Document Control
- Quality
- Assurance
- Patient Safety

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**:

- 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.

**Document** **Control**:

- 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.

**Quality Assurance**
- 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 ch

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