CAPA Remediation Specialist

Job type:
Start date:
Quanta Consultancy Services
Published at:
flag_no Switzerland
Contact person:
Lee Mitchell
Project ID:

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Our Global Medical Device client is looking for an experienced CAPA Remediation Specialist to support their 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.

Start: September 2014
Duration: 6-12 months
Location: Canton Zurich, Switzerland

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.

• Degree educated with strong experience within the Medical Device and Pharmaceutical industry.
• 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.
• Excellent organisational, interpersonal, written and oral communication skills required.
• Fluent German and English language skills.

Please apply now for this challenging, long-term position!