Quality Assurance Specialist Role
We are seeking a Quality Assurance Specialist to join our team at TCP Homecare.
About the Role
The Quality Assurance Specialist will be responsible for the administration and maintenance of the TCP Homecare Quality Assurance system as well as supporting the Head of Quality and Patient Safety in adherence to Quality & Safety best practice standards.
Key Responsibilities
* Ensure effective and efficient processes are established, implemented and maintained for the Quality Management System (QMS).
* Raise and manage change controls and risk assessments procedures at TCP Homecare, in conjunction with the Head of Quality and Patient Safety and relevant area managers.
* Document and Records Management: Ensure that document control procedure is managed to approve, review and update all changes to critical documents within the scope of the QMS.
* Assist in the development of policies, procedures and initiatives that maximise the quality of work in all business operations teams.
* Ensure records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for identification, storage, protection, retrieval, retention time and disposition of such records.
Audits
* Ensure 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.
Management of Equipment (GDP)
* Assist in the validation of new equipment & systems.
* Coordinate and manage all aspects of temperature monitoring and calibration of temperature monitoring devices.
Incident and Change Management
* Manage the Incident Management System at TCP.
* Assist with effective corrective / preventive actions (CAPAs) resulting from complaints, incidents or audit non-conformances.
Communication, Reporting and Training
* 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.
* Produce reports and provide regular quality performance updates to the leadership team.
* Attend management meetings to represent the quality department and highlighting any items relating to the QMS.
Requirements
* Third Level Qualification in a Scientific/Quality discipline.
* Experience of working in a similar Quality Assurance related role in the Pharmaceutical/Healthcare Industry.
* Previous technical writing experience.
* Excellent organisation and problem solving ability.
* Excellent attention to detail and communication skills.
* Demonstrate an ability to work to deadlines and on own initiative.
* Knowledge of statistical methods and Six Sigma tools would be an advantage.
* Ability to take existing procedures and work with teams to find opportunities to streamline or improve.
What We Offer
* Competitive annual salary.
* 24 days of annual leave, rising with service.
* A supportive and friendly working environment.
* Training courses and opportunities to up-skill.
* Promotional opportunities.
* Refer a Friend scheme.
* Social events.
Skills Required
* Validation.
* Audit.
* Technical writing.
* Attention to detail.
* Problem solving.