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