Scientific Technical Specialist

The Scientific Technical Specialist will support the Downstream Operations Team as part of a broader Technical Operations group. This individual will play a critical role in contamination control and quality risk assessments (QRA), ensuring compliance with GMP (Good Manufacturing Practices) and supporting cross-functional operations.

Key Responsibilities

Risk Lead for Contamination Control and Downstream QRA

• Act as the risk lead for contamination control and downstream QRA.
• Own pre-work preparation, lead review sessions with interdisciplinary teams, and manage QRA updates and approvals in the electronic GMP system.

Downstream Quality Risk Assessments (QRA) Management

• Ensure timely, accurate, and efficient handling of documentation, including access and revision control.
• Serve as a QRA contributor to other risk assessments on-site.

Documentation Management

• Oversee "Live" documentation updates from the operations floor.
• Issue and update documentation according to the Operations Schedule.
• Implement and manage a floor documentation control system.
• Drive the Documentation Life Cycle System to ensure timely document approval as per schedule.
• Collaborate with Subject Matter Experts (SMEs) to finalize technical documentation.

Standard Operating Procedures (SOPs) and Work Instructions

• Create and revise SOPs and Work Instructions (WIs) as required.
• Cross-Functional Collaboration
• Work closely with QA, Supply Chain, and Operations to ensure streamlined processes.
• Maintain strict compliance with GMP, Safety, and Environmental requirements.

Experience

• Prior experience in a GMP-regulated, pharmaceutical environment.
• Familiarity with GMP Documentation Management Systems.
• Preferred: Degree in a scientific discipline with experience in the biopharmaceutical industry.

Skills

• Strong organizational and time-management abilities.
• Excellent written and verbal communication skills.
• High attention to detail and accuracy.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Ability to work independently and within a collaborative, cross-functional team environment.

The Next Step for you:

Should this position be of interest to you please forward your CV to Barry O'Mahony from Next Generation Recruitment or alternatively call on the main line on 016629120

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

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