Scientific Technical Specialist - P2

Location: Swords, Dublin (Onsite)

Contract Role

Role Overview

The Scientific Technical Specialist will support the downstream operations team as part of the Technical Operations function. This role involves leading quality risk assessments, managing documentation systems, and collaborating with cross-functional teams to ensure regulatory compliance and operational excellence.

Key Responsibilities

• Risk Management:
• Act as risk lead for contamination control and downstream Quality Risk Assessments (QRAs), including preparation, facilitation of review sessions, and approval processes on the GMP system.
• Contribute to site-wide QRAs as a subject matter expert.
• Documentation Management:
• Manage and update live documentation from the operations floor in line with the schedule.
• Drive the document lifecycle system to ensure timely approval of documents.
• Collaborate with subject matter experts to revise and approve technical documentation, including SOPs and Work Instructions.
• Implement and maintain on-the-floor documentation control systems.
• Cross-Functional Collaboration:
• Partner with QA, Supply Chain, and Operations to ensure alignment and compliance.
• Support regulatory GMP, safety, and environmental standards.

Qualifications and Skills

• Education:
• Degree in a relevant field, with biopharmaceutical experience preferred.
• Experience:
• Pharmaceutical GMP-regulated industry experience.
• Proficiency with GMP documentation management systems.
• Key Skills:
• Excellent organizational and communication skills.
• Strong attention to detail and ability to work independently or collaboratively in cross-functional teams.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).
• Solid interpersonal skills and a self-motivated approach.

 

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Hannah Doyle on 086 107 0950 Engineering@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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