Job Description

MAIN DUTIES & RESPONSIBILITIES

• Maintain and update quality procedures within the quality management system.
• Assist in the tracking of CAPAs, change controls, and deviations to ensure timely closure.
• Generate reports and dashboards for quality metrics and KPIs.
• Reviewing temperature control deliveries and releasing of stock.
• Logging of adverse events and product quality complaints.
• Logging of distribution complaints.
• Support with audit preparation for regulatory inspections and client audits.
• Maintain audit schedules and track completion of audit CAPAs.
• Review and Approval of Customer and Vendor Setups.
• Assisting with carrying out annual Bona Fides checks.
• Review and approval of product setups.
• Administration and support of Recalls/Quarantine Requests.
• Monitor and document temperature data from shipments, including downloading logger data and filing excursion reports.
• Supporting with annual GDP and GVP training.
• Any other quality duties which may arise.

QUALIFICATION, EXPERIENCE & SKILLS REQUIRED

• A third level qualification in science is preferred but not essential.
• Experience in the operation of the WMS.
• Excellent PC skills, including Word & Excel PowerPoint etc.
• Previous experience of administration duties an advantage

COMPETENCIES

• Excellent written communication skills.
• Excellent telephone manner.
• Highly organized & efficient – with an ability to multitask.
• Excellent interpersonal skills – with an ability to interact with all of staff, management, customers & clients.
• An ability to prioritise and work under pressure.
• An ability to meet deadlines.