SENIOR QUALITY 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.

QUALIFICATIONS / EXPERIENCE REQUIRED

• Relevant experience (3yrs +) 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 SAP and Awards and using spreadsheets and email.
• 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.

OVERVIEW/PURPOSE OF THE ROLE

Responsible for providing quality support within the warehouse / distribution / manufacturing operations at United Drug - Goods Receipt, Stock Disposition, Returns, FMD support - in addition to reviewing quality standard for house-keeping , pest control and GDP documentation within the warehouse (s).

KEY RESPONSIBILITIES

• Conduct Quality Inspections of incoming goods to ensure compliance with specified plans including: Temperature review, Artwork inspections, Exempt checks, Controlled Drugs licence activities, FMD activities.
• Co-ordinate the release of the goods with the Principal in a timely manner according to GDP.
• Collaborate with Operations to drive Quality awareness, facilitate GDP and implement improvements.
• Responsible for disposition of product (Quarantine and Release) using SAP Responsible for generation and provision of the Controlled Drugs report to external bodies
• Conduct inspections of returned medicinal products
• Coordination of analytical/reference/retain and artwork samples programme.
• Regular review of Warehouse Log-books
• Communicate deviations to GDP standards and document investigations into root cause in order to identify appropriate CAPA
• Utilise a continuous improvement approach in all aspects of role
• Participate in customer and regulatory audits to assure compliance to GDP.
• Perform regular review of the Pest Control programme at UD
• Perform sampling activities and / or in-process checks as described in each Batch Record Instruction (PPS)
• Provide support to operations teams as part of FMD
• Provide support to the new product / new account set up process.
• Liaise with KAM’s and directly with Principals in relation to stock availability.
• Ensure that appropriate SOPs, Quality Summary sheets and Work Instructions are generated and maintained.
• Write, execute and manage protocols relating to vendor transfers, complex product changes and ad hoc activities that involve quality control.
• Create inbound inspection plans and update product master records.
• Participate in internal audit programme.
• Participation in cross functional projects and subject matter expert in QC tasks.