Quality Team Lead This job description sets out the scope of the role of the Quality Team Lead with the main duties of the position at the date when it was completed.
It does not include or define all responsibilities or duties which the post holder may be expected to carry out.
Duties may vary from time to time without changing the nature of the post or the level of responsibility.
The post holder may also be required to carry out any other duties to co-operate with the general work of the organisation, as required by their line or department manager.
Overview / Purpose of the Role Reporting to the Quality Manager, act as the Lead within the Quality team ensuring team members are trained and supported in the provision of quality support to UD Customers (internal and external), Suppliers and Health Authorities in accordance with GDP & GMP requirements.
Key Responsibilities Support the Quality Manager in leading the Quality team.
Responsible for managing the site Operational Quality activities according to GDP including: o Overall responsibility for Incoming Material Inspections in Pre-Wholesale on behalf of Vendors (~5,000 Materials and ca.
100 Vendors) which includes: - Controlled Drugs License reporting and reconciliation Unlicensed Medicines Inspection and reporting Stock Management; Quarantine, Release, Vendor Specific Orders Provide Quality support to GMP Operation (Secondary Packaging) including management of retain and reference sample program on behalf of Vendors Overall responsibility for United Drug approach to Falsified Medicines Directive to all operations process in United Drug business (Pre-Wholesale and Wholesale) Management of Returned Product Inspections Ensure deviations and complaints are recorded and progressed with Root Cause identification and appropriate CAPAs Preparation, review and / or approval of GDP documentation, including SOPs, Work Instructions, forms and principal specifications Support internal and external GDP/ISO inspection programs including GxP vendors and suppliers' audits Managed the MIA licences, related QMS activities and batch release.
Be the deputy RP on United Drug Wholesale Distribution Authorisations (WDA).
Manage the Approved Vendor Process, including Vendor Appraisal, Approval process, periodic reviews and audits.
New product introduction, set-up and review of supply maps.
Manage Supplier & Customer set-up process, including the approval of Bona-Fides and Establish and monitor KPI's for QMS and Quality activities.
1st point of contact for escalations from Key Account Managers.
Build team skills through skills assessment, training, feedback, and support.
Undertake specific projects as required and ensure the team participate in any Continuous Improvement projects.
Compile training material for Quality systems.
Ensure team members adhere to relevant procedures and support a strong customer focus while coaching the team on how to manage their day in a productive way.
Task Allocation - Ensure workload is evenly distributed between the team and that sufficient cover is available at all times.
Remain aware of developments in the quality field by reading current quality / regulatory literature and attending relevant meetings and workshops.
Manage the ongoing performance of direct reports.
Other duties not identified above may be required Key Experience / Skills / Education Relevant experience (3yrs +) working in the pharmaceutical industry, manufacturing, retail pharmacy or distribution Minimum Bachelor Degree in Life Science essential, Detailed knowledge of applicable regulatory requirements including working knowledge of current Good Manufacturing Practise, current Good Distribution Practice (GDP), medical devise and Falsified Medicines Directive (FMD).
Strong organizational skills, including ability to follow assignments through to completion.
Demonstrated ability in problem solving.
Track record of continuous personal development.
Attention to detail with a high level of accuracy.
Proficient in Microsoft Office, Proficient in SAP or other WMS an advantage.
Excellent communicator, with strong negotiation and influencing skills Highly collaborative, with ability to work constructively and positively influence and engage colleagues and internal stakeholders.
Strong leadership skills About United Drug United Drug is Ireland's largest pharmaceutical distribution company and was originally founded by a group of pharmacists in Ballina, Mayo in 1948.
In 2022 United Drug became part of the PHOENIX group and is now part of Europe's leading healthcare provider in the sector.
Employing more than 650 staff across operations in Dublin, Limerick and Mayo, we partner with more than 1,900 pharmacies, hospitals, clinics and primary care centres across Ireland.
Our business spans across three business units; United Drug Wholesale, United Drug Distribution and United Drug Consumer - all leaders in their respective categories.
About PHX Ireland & PHOENIX Group PHX Ireland Group is Ireland's leading fully integrated healthcare provider.
We deliver health.
We are comprised of United Drug, Ireland's leading pharmaceutical wholesaler and distributor; LloydsPharmacy Ireland, a major community pharmacy chain; and TCP Homecare, innovators in clinical home nursing services and direct to patient delivery solutions.
PHX Ireland Group employs over 1,800 people, operate 5 distribution centres and over 75 pharmacies, delivers over 85 million packs to Irish pharmacies and hospitals and serves 500,000 patients each year.
By working together to provide these solutions, PHX Ireland can enable a sustainable healthcare system and support Irish Healthcare.
PHX Ireland is part of the PHOENIX group, Europe's leading healthcare provider.
Headquartered in Mannhein, Germany, the PHOENIX group brings together more than 48,000 employees from 29 countries, includes 223 pharmaceutical distribution sites, and more than 3200 owned pharmacies and 17000 partner pharmacies.
Every day, the PHOENIX group makes an important contribution to comprehensive and safe healthcare in Europe.
We strive to foster an open and inclusive environment, embracing applications from individuals of all backgrounds.
Our commitment lies in ensuring an accessible interview process for all candidates.
If you require additional support or accommodations to attend an interview, we kindly encourage you to reach out to ******