Quality Compliance Specialist This job description sets out the scope of the role of the Quality Compliance Specialist , 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 Working as part of the Quality Team, the Quality Specialist will support the business in ensuring compliance with Good Distribution Practice (GDP) and the requirements of ISO 9001.
Key Responsibilities Participate in the external audit programme.
This will involve conducting Principal Audits for UDD / UDC / UDW.
Manage GxP Vendors Participate in regulatory audits, to include preparation, attending throughout the audit and involvement in the follow up of any findings Management of the internal audit schedule.
Ensuring the schedule is adhered to and assisting the audit team to ensure the audits and any follow up actions are completed on time. Provide Quality support to the Document controller. Participate in the periodically review of Bona-Fides.
Interaction with the HPRA and Marketing Authorisation Holders, ensuring compliance with regulatory and quality requirements.
Provide training on aspects of QMS and ensure relevant personnel involved in GDP operations are trained and records maintained.
Assist with deviations from GDP, identification of root cause and ensure CAPAs are identified and implemented as defined.
Support the Change Control Programme.
Principal management, including T&Q's, KPI's and other requests. Keep up to date on regulatory requirement and changes to regulations Other duties not identified above may be required.
Key Experience / Skills / Education Demonstrates good verbal, written, and interpersonal communication skills.
Strong organizational skills, including ability to follow assignments through to completion Relevant experience (3yrs +) working in the pharmaceutical or regulated distribution industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Knowledge of applicable regulatory requirements including working knowledge of current Good Distribution Practice (GDP).
Qualification in a life science and/or willingness to complete 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.
The business spans across three business units; United Drug Wholesale, United Drug Distribution and United Drug Consumer - all leaders in their category.
About PHX Ireland & PHOENIX Group As Irelands leading fully integrated healthcare provider, we are proud of our mission - We deliver health.
PHX Ireland Group employs over 1,800 talented and experienced people, all passionate about supporting their customers and patients and striving to enhance the quality of life for millions of patients every single day.
We operate 5 distribution centres, pharmacies nationwide, deliver over 85 million packs to Irish pharmacies and hospitals, and serve over 500,000 patients each year.
By working collaboratively together to provide these solutions, PHX Ireland can enable a sustainable healthcare system and support Irish Healthcare needs.
PHX Ireland is part of the PHOENIX group.
Having access to Europe's leading healthcare provider helps us grow and evolve, by adopting best practice, and sharing insights, processes, and expertise we can continuously improve our offering and drive Irish Healthcare forward.
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 ******