QA Scientist (On-site)

Job summary

This role involves quality assurance within a biotechnological production environment, focusing on ensuring compliance with GMP standards and patient safety. The position is a fixed-term maternity cover for nine months.

Qualifications

• Relevant science-based Master’s degree
• Experience in QA and GMP within the biopharmaceutical industry, preferably in manufacturing support
• Fluency in written and spoken English

Responsibilities

• Coordinate resolution of significant quality issues with clients
• Conduct QA review and approval of technical documents, including Batch Production Records, Change Controls, Deviations, CAPAs, DS specifications, Master Production Records, and Risk Assessments
• Support development and improvement of department SOPs
• Liaise with internal and external stakeholders to resolve issues
• Assist in negotiating Quality Agreement terms with clients and support client audits

Skills

• Self-motivated with a proactive and pragmatic approach
• Ability to prioritize and balance multiple tasks in a fast-paced environment
• Strong communication and collaboration skills

Education

• Master’s degree in a relevant scientific field

Tools

• Familiarity with GMP regulations and quality assurance processes