QUALITY COMPLIANCE TECHNICIAN

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.
United Drug are hiring a Quality Compliance Technician responsible for supporting key activities within the Quality Compliance team.

Responsibilities:

• Collaborating cross-functionally to manage the lifecycle of over 3,000 controlled documents within the Document Management System (DMS).
• Monitoring key performance indicators (KPIs) and delivered comprehensive organization-wide compliance reports related to documentation practices to support continuous improvement initiatives.
• Preparing and submitting when required, licence variation applications to The Health Products Regulatory Authority (HPRA) and managed their integration and tracking within the QMS.
• Participating as a support auditor in internal audits, contributing to compliance assurance and audit readiness.
• Key user in all QMS databases including E-Learning and M-Files
• Utilise a continuous improvement approach in all aspects of role
• Performing regular training as per United Drug training procedure and GDP/GMP guidelines
• Collaborate with Operations to drive Quality awareness, facilitate GDP/GMP and implement improvements.
• Participation in cross functional projects and subject matter expert in QC tasks with a particular emphasis on Document Management.
• Provide Quality support to ensure that the following systems comply with GDP & GMP legislation
• Document Management
• Deviation Management
• Training
• Change Management
• Sub-Contractor Management
• Audit (Self-Inspection)

Requirements:

• Strong IT skills, with experience in working with Documentation Management Systems an advantage.
• Relevant experience (2yrs +) working in the pharmaceutical or regulated distribution industry.
• Strong communication skills and the ability to work well with people at all levels of the organisation.
• Working knowledge of current Good Distribution Practice (GDP).
• Strong organizational skills, including ability to follow assignments through to completion.
• Demonstrated ability in problem solving.
• Attention to detail and good follow through with a high level of accuracy.
• Ability to work towards deadlines.
• Ability to work to work independently.

• Collaborating cross-functionally to manage the lifecycle of over 3,000 controlled documents within the Document Management System (DMS).
• Monitoring key performance indicators (KPIs) and delivered comprehensive organization-wide compliance reports related to documentation practices to support continuous improvement initiatives.
• Preparing and submitting when required, licence variation applications to The Health Products Regulatory Authority (HPRA) and managed their integration and tracking within the QMS.
• Participating as a support auditor in internal audits, contributing to compliance assurance and audit readiness.
• Key user in all QMS databases including E-Learning and M-Files
• Utilise a continuous improvement approach in all aspects of role
• Performing regular training as per United Drug training procedure and GDP/GMP guidelines
• Collaborate with Operations to drive Quality awareness, facilitate GDP/GMP and implement improvements.
• Participation in cross functional projects and subject matter expert in QC tasks with a particular emphasis on Document Management.
• Provide Quality support to ensure that the following systems comply with GDP & GMP legislation
• Document Management
• Deviation Management
• Training
• Change Management
• Sub-Contractor Management
• Audit (Self-Inspection