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 (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 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 Skills: Microbiology Risk Assessment Sterile Fill Finish