Quality Operations Officer

4 weeks ago

Dublin, Ireland United Drug Full time

Quality Operations Officer


This job description sets out the scope of the role of the Quality Operations Officer 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

 

Responsible for providing quality support within the warehouse / distribution / manufacturing operations at United Drug - Goods Receipt, Stock Disposition, Returns, New Product Introduction, Complaints Management, FMD support - in addition to reviewing quality standard for house-keeping, pest control and GDP documentation within the warehouse (s). The role is based in Magna Park but may require travel to other United Drug sites.

 

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.
  • Ensure that appropriate SOPs and Work Instructions are generated and maintained.
  • Responsible for disposition of product (Quarantine and Release) using SAP
  • Responsible for generation and provision of the Controlled Drugs report to external bodies
  • Support the setup processes for new products, vendors and customers at United Drug
  • Establish and regularly review vendor and customer Bona-Fides including management of principal specific orders
  • Communicate deviations to GDP standards and document investigations into root cause in order to identify appropriate CAPA

      Manage the product Quality Defects / Adverse Events report to MAH, Supplier and Regulatory Authorities

  • 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)
  • Create inbound inspection plans and update product master records
  • Provide support to operations teams as part of FMD
  • Liaise with KAM's and directly with Principals in relation to stock availability.

 

Other duties not identified above may be required

 

Key Experience / Skills / Education

  • Relevant experience (2yrs +) 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.
  • Life Science diploma or degree in a related discipline preferred.
  • Working knowledge of SAP in particular QM Module and Master Data.
  • Detailed Knowledge of applicable Regulatory requirements including working knowledge of current Good Distribution Practice (GDP)
  • Demonstrates good verbal, written, and interpersonal communication skills.
  • Strong organizational skills, including ability to follow assignments through to completion
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations preferred.
  • Attention to detail and good follow through with a high level of accuracy
  • Ability to work towards deadlines
  • Strong focus on customer needs and customer service.
  • Awareness of Health & safety and GDP requirements.
  • Ability to plan effectively is essential for this role
  • Strong Analytical Skills
  • Ability to work both independently and as part of a team


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 jobs@phxireland.ie

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