Job Title: Quality and Operations Associate
Position Overview:
Daily handling of Operational and Quality Activities within the KBFL Sciences Facility to ensure the timely, efficient and GDP compliant receipt, storage and delivery of Medicinal Products for Human Use.
Reporting to: Operations and Compliance Manager.
Operational Activities:

• Timely order receipt and processing via the High Tech Hub and Inventory Management System.
• Conduct Picking and Packing activities in compliance with GDP, to fulfil customer orders.
• Preparation of customer invoices and statements.
• Preparation of logistics and shipping documentation.
• Maintain the KBFL Inventory Management System.
• Engage with logistics partners for the provision of services for nationwide deliveries, including route planning and cost analysis.
• Reconciliations (Inventory/Accounts/Logistics).
• General Reception duties (Including phone calls, post delivery and receipt).
• Respond to inbound/outbound queries and/or complaints from customers/vendors/outsourced partners.
• Receiving and dispatching medicinal products following the company’s procedures
• Restock shelves and maintain organisation within the warehouse.
• Initiate and participate in the investigation of Customer Complaints and escalation of these in a timely manner.
• Work with Facilities Manager and Operations and Compliance Manager to develop and implement a robust Health and Safety System.

Quality Activities:

• Assist the Quality and Compliance Manager / RP in maintaining high levels of compliance within the Quality Management System
• Initiate and participate in the investigation of Quality Deviations.
• Initiate and participate in Change Controls, Risk Assessments, Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA).
• Assist the RP with the Self-Inspection Process – assist in the Internal Audit Program; review Standard Operating Procedures, Standard Documents, Work Instructions, Logs and internal Quality Processes to ensure compliance to GDP and highlight any deficiencies.
• Daily review of temperature-controlled delivery data to ensure medicinal products have been transported in compliance with manufacturer specifications.
• Daily review of (Electronic Temperature Monitoring System) EMS to ensure temperature control compliance of our Ambient and Cold Room Warehouses.
• Quality Assurance Receipt of Medicinal Products, including a full QA inspection and FMD check (Falsified Medicines Directive) on all batches received into KBFL.

Additional Responsibilities:
Participate in training and development as required.
Cover the duties of the second Quality and Operations Associate during absences.

• Cooperate and collaborate with the entire team.
• Performance of additional tasks as required by management.

Requirements:

• This role is an essential function as part of a small team. Therefore, the suitable candidate will successfully demonstrate the following key attributes;
• Detail oriented
• Organisation
• Communication
• Problem-solving
• Decision-making
• Flexibility
• An excellent team player, who takes responsibility and ownership of tasks.
• Prior knowledge and experience of working in Operations is desirable.
• Prior knowledge and experience of working in Quality is desirable.
• Proficiency in Microsoft Office applications is essential.
• Ability to follow directions and work with moderate supervision.
• Ability to use initiative and to be proactive.
• Proven attention to detail.

Working Hours:

• 40 Hour working week inclusive of paid breaks.
• 8 hour working day- 9-5pm -Monday to Friday, Flexibility depending on business needs.

Range of benefits include:

• EAP (Employee Assistance Programme)
• Company pension plan
• Treatment benefits
• Company health insurance plan
• Additional annual leave
• Paid additional sick leave plan
• Paid maternity/paternity leave benefits
• Monthly Lunches
• Quarterly Activities/Parties
• A range of other benefits

Job Type: Full-time
Pay: €30,000.00-€34,000.00 per year
Benefits:

• Additional leave
• Bike to work scheme
• Company events
• Company pension
• Employee assistance program
• Employee discount
• On-site parking
• Private medical insurance
• Sick pay

Schedule:

• Monday to Friday

Work authorisation:

• Ireland (required)

Work Location: In person
Reference ID: Quality and Operations Associate