Downstream Technical Specialist

PE Global are currently recruiting for a Scientific Technical Specialist -Downstream Operations on behalf of our client based in Dublin:

11 Month initial contract  – Days

Role Description

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

Role Functions

(Functions include, but are not limited to, the following)

• 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.

Experience, Knowledge & Skills

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 & Education

Qualifications:

• At minimum, Degree in a relevant Qualification and Biopharmaceutical experience

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***