The Quality Assurance Officer is a dedicated professional and is a key in supporting and maintaining an essential and effective Quality Management System (QMS).
Reporting to the Quality Manager (QM), the Quality Assurance Officer shall undertake responsibilities assigned by the QM, with a key focus on maintaining accurate records, assisting with continuous improvement of the QMS, coordinating and monitoring of quality initiatives and activities.
The Quality Assurance Officer shall have appropriate competence, experience, as well as knowledge of and training in Good Distribution Practice and have personal knowledge of EU legislation in medicine.
The Quality Assurance Officer must also adhere to Health Products Regulatory Authority (HPRA) issued guides, including but not limited to the below:

• IA-G0008 - Wholesaling and Brokering of Medicinal Products for Human Use in Ireland

• IA-G0046 - Good Distribution Practice of Medicinal Products for Human Use

• SUR-G0019 – Recall of Medicinal Products for Human and Veterinary Use

• AUT-G0152 - New Applications and Variations to Wholesale Distribution Authorizations

The Quality Assurance Officer shall also, when called upon to support Operation duties that may involve in the coordination of incoming and outgoing planning with Midwinter customers, suppliers and service providers.
The Key attributes and skills of the Quality Assurance Officer shall:

• Be a good communicator

• Self-motivated

• Great organisational skills

• Flexible and adaptable

• With a keen eye for details

• Be willing to contribute

• Be inquisitive and promote improvement solutions.

Core Responsibilities
· Maintain Document Control process to ensure latest QMS documentations are made readily available within Midwinter Solutions site..
· To assist with the preparation and participate where necessary, clients or regulatory audits of Midwinter Solutions site.
· Participate in Change Management process and assisting or facilitate in the implementation of the change to ensure completion within the specified time line.
· Administrative responsibility in scheduling Quality Meetings, recording, filing and distribution of minutes.
· Collating and record keeping of operations’ transactional documents specific to Midwinter solutions sites.
· When requested by the Project Manager, to coordinate with suppliers, service providers and customers to ensure delivery of products meet client expectations and comply with product specification, specific to a Project.
· Issuing companywide email communication following any regulatory updates/alerts/shortages notifications.
· Assisting the flow of information between Midwinter Solutions sites and the Project and Quality Team
· Reporting identified quality incidents arising at Midwinter Solutions site to the Quality Manager
· To support in the investigation of complaints and internal deviations process.
· Assist in the management of Quality Incidents with suppliers and service providers to ensure they are effectively investigated and appropriate corrective and preventative measures applied.
· Monitoring and progressing regulatory product recall process and liaising with internal departments for reconciliation and closure.
· To participate and conduct Internal audit following competency approval.
· Collaborate with Project Managers to manage Operations related quality assurance deadlines
· Maintain and prepare internal training presentations and competency assessments.
Responsible for the office environment to ensure it is clean and secure with equipment maintained and operational at all time.
Job Types: Full-time, Permanent
Pay: €30,000.00-€33,000.00 per year
Additional pay:

• Yearly bonus

Benefits:

• Company events
• Company pension
• On-site parking

Schedule:

• Monday to Friday

Work Location: Hybrid remote in Backlands, Drumillard Little, CO. Monaghan
Reference ID: QAO-MWS EU