Beschreibung
Profile 1: CAPA Consultant (Subject Matter Expert)Responsibilities:
- Support for CAPA process on site
- appropriate Investigation and Root Cause Analysis
- definition of appropriate actions (corrections, corrective actions, preventive actions) with including the required documentation according to regulation 21 CFR
Requirements:
- industrial practice in CAPA process in medical device or pharmaceutical industry
- knowledge of regulation and standards like ISO 13485, 21 CFR 820
- Fluent English and German
Profile 2: CAPA Legacy Review
- Perform CAPA Legacy Reviews per protocol per schedule
- Engage with local CAPA and site process SMEs to ensure adequate review of CAPA content and product and process risk
- Alert management of product quality & compliance issues for proper and timely escalation to CAPA
Requirements:
- Expert knowledge of the US Quality System Regulations and ISO 13485
- Fluent in German and in English - able to review CAPA documents & interact with CAPA & site process SMEs
- Strong knowledge of quality and compliance for Medical Device Industry (GMPs)
- Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
- A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
Start Date: ASAP
Duration: 6 months
Location: South Germany, Austria, Switzerland (onsite, negotiable)
If you are interested, feel free to contact me via email and I will call you as soon as possible.