Scientific Technical Specialist required for a leading Biotech facility in Dublin, to support the downstream technical team supporting Operations.
Initially an 11 month contract.
Role: 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 (WIs) 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 Science, engineering or manufacturing discipline.
Biopharmaceutical experience At least 3-4 years experience working in a Pharmaceutical GMP regulated industry.
Evidence of Continuous Professional Development.
Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
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 Skills: Scientific Specialist Science Biotech