The Role
Maintain and update quality management system procedures; track CAPAs, change controls, deviations; manage temperature-controlled stock, complaints, recalls and audit preparation; generate quality KPI reports and support GDP/GVP training.
Summary Generated by Built In
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.
Skills Required
- Experience in the operation of the WMS
- Excellent PC skills, including Microsoft Word, Excel and PowerPoint
- A third level qualification in science
- Previous administration experience
- Excellent written communication skills
- Excellent telephone manner
- Highly organized and able to multitask
- Excellent interpersonal skills
- Ability to prioritise and work under pressure
- Ability to meet deadlines
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The Company
What We Do
Uniphar is a diversified healthcare services organisation with activities in Ireland, UK, Europe, the USA and APAC
