Quality Assurance Specialist - Hybrid
TCP Homecare is a healthcare service provider, specialising in 'direct to patient services' which include the dispensing and distribution of pharmaceutical products, homecare nursing services and sharps waste management, facilitating a unique turnkey solution for the delivery of hospital care in the patient's home.
The Quality Assurance Specialist is responsible for administration and maintenance of the TCP Homecare Quality Assurance system as well as supporting the Head of Quality and Patient Safety in adherence of Quality \& Safety best practice standards.
This is permanent, full time, Monday to Friday role with attractive hybrid working available.
Key Responsibilities:
Quality Management
- Ensure that effective and efficient processes required for the Quality Management System (QMS) are established, implemented and maintained.
- Raise and manage the change controls and risk assessments procedures at TCP Homecare, in conjunction with the Head of Quality and Patient Safety and relevant area managers.
- Ensure that the document control procedure is managed to approve, review and update all changes to critical documents within the scope of the QMS. Assist the development of policies, procedures and initiatives that maximises the quality of work in all business operations teams.
- Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.
- Ensure that an internal audit programme is implemented to verify that the QMS conforms to planned arrangements.
- Assist, participate and lead as required in internal, client and regulatory audits at TCP Homecare
- Assist in the validation of new equipment \& systems
- Coordinate and manage all aspects of temperature monitoring and calibration of temperature monitoring devices
- Manage the Incident Management System at TCP
- Assist with effective corrective / preventive actions (CAPAs) resulting from complaints, incidents or audit non\-conformances.
- Assist in the analysis of quality\-related customer complaints and implementing corrective action.
- Liaise with Operations staff and other members of the Quality team on all quality issues.
- Continuous review and evaluation of all business units in accordance with the requirements of ISO 9001, GDP, HPRA and HIQA recommendations.
- Analyse data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
- Produce reports and provide regular quality performance updates to the leadership team and clinical governance committee
- Attend management meetings to represent the quality department and highlighting any items relating to the QMS.
- Report to the Head of Quality and Patient Safety on the performance of the QMS and any need for improvement.
Third Level Qualification in a Scientific / Quality / Healthcare / Food Science discipline.
Experience of working in a similar role in the Pharmaceutical/Healthcare/ Food Industry with a quality related function (minimum 2 years)
Experience of working in a GDP environment would be an advantage
Excellent organisation and problem solving ability.
Excellent attention to detail and communication skills.
Demonstrate an ability to work to deadlines and on own initiative.
Ability to take existing procedures and work with teams to find opportunities to streamline or improve.
What We Offer in Return:
Competitive annual salary
Pension Scheme
Health Insurance
Income Protection
Life Assurance
24 days of annual leave in a full calendar year
Employee Discount Card
A supportive and friendly working environment
Regular training courses and opportunities to up\-skill
Refer a Friend scheme
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