QUALITY COMPLIANCE OFFICER

Our people make the difference. Here at PHX Ireland, we strive to be a place for everyone - where each and every one of us can be our true, authentic selves, every single day.
For us, individuality sparks new ideas, shapes new approaches and brings us powerful new perspectives. It’s the heartbeat of our innovation, creativity, and success. Which is why, at PHX Ireland, we don’t just embrace our differences - we celebrate them.
Across United Drug, McCabes Pharmacy, and TCP Homecare, in every location and every role, the way we work makes us who we are - and that’s something we are really proud of. Which is why we’ve summed up our ethos in our six PHX Ireland values; Customer focused, Quality driven, collaborative, ambitious, innovative, and inclusive.

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. Our business spans across three business units; United Drug Wholesale, United Drug Distribution and United Drug Consumer - all leaders in their respective categories.

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 DUTIES

• 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