Description
A leading biotechnology client is looking for experienced CAPA Remediation Specialists to support its compliance improvement project on site.This role will be part of a wider quality improvement project being carried out across all QA work streams, to drive regulatory compliance to an outstanding level.
Working internationally, these are initial 6 month contracts.
Key Responsibilities:
• Carry out full lifecycle CAPA management and CAPA handling to close out deviations.
• Write reports and documentation following internal templates.
• Liaise with internal stakeholders.
• Ensure all processes are GMP compliant.
• Proactively examine CAPA systems, processes, and standards to identify areas for review, change, or elimination.
• Analyse and report CAPA tracking and trending results and system performance metrics.
Experience required:
• Experience working in a Manufacturing, Engineering, Quality Assurance or similar field in a regulated environment required.
• Proven experience in CAPA management and CAPA handling.
• Experience working with a CAPA system required.
• In-depth knowledge of ISO and GMP requirements, with specific focus on CAPA required.
• Excellent technical understanding.
• Ability to work independently in a pressurised environment.
• Strong analytical and problem-solving skills.
• Ideally high speed, filling line experience from a sterile or aseptic environment
• Excellent organisational, interpersonal, written and oral communication skills required.
• Strong interpersonal skills and capable of dealing with conflict
• International manufacturing/production experience (EU, US, Asia-Pac)
• Patience and perseverance very important skills to have due to the location
• Having worked in a foreign location and having cultural awareness would also be very helpful
For further detail on these exceptional roles, please contact Jenny Latham on + or apply with your CV.