Technical Specialist

· 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.

Key Competencies & 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

Qualifications:

At minimum, Degree in a relevant Qualification and Biopharmaceutical experience