22226 – Quality Specialist – Dublin Contractor

Purpose
Scientific Specialist supporting the downstream operations team. Successful candidate will be part of a Technical Operations team supporting Operations.

Responsibilities

• Individual will hold the position of risk lead of the contamination control and downstream QRA (quality risk assessments- involves owning all pre work, holding and leading reviews sessions with interdisciplinary teams, and owning the update and approval of the QRA on the electronic GMP system)
• Responsible for Downstream Quality Risk Assessments (QRA’s), including contamination control QRA’s Responsibility for the timely, accurate and efficient management of documents including access and revision control.
• Hold the position of QRA contributor to other risks assessments on site.
• Manage “Live” Documentation updates from the operations floor.
• Turnaround and issue documentation as per Operations Schedule
• Manage and implement on the floor documentation control system.
• Drive the Documentation Life Cycle System to ensure documents are approved in as per Scheduling requirements.
• Work with various Subject Matter Experts to ensure technical documentation updates are approved.
• Creation and revision of Standard operating Procedures (SOPs) Work Instructions (WI’s) as required
• Work closely with QA, Supply chain and Operations core functions
• Ensure compliance with all regulatory GMP, Safety and Environmental requirements.

Requirements

• Degree in a relevant Qualification and Biopharmaceutical experience
• Self-motivated with excellent organizational skills
• Experience Working in a Pharmaceutical GMP regulated industry.
• Excellent verbal and written communication skills
• Ability to work independently and as part of a team in a cross functional collaborative environment.
• High level of attention to detail
• Experience working with GMP Documentation Management Systems
• Proficient in Microsoft Office Tools (word/excel/PowerPoint)
• Good interpersonal skills