Beschreibung
Rate: 100 – 140 CHF (€80 – €115)Duration 6-12 months (ideally full-time: 40 hours / week)
Following GAP Analysis of 100+ Pharmaceutical manufacturing distribution centre documentation files, a QA Consultant is required to review, sanitise and remediate 2 year-old files in line with FDA regulations. This major top-10 Pharmaceutical / Devices Company works in developing innovative medical devices, biopharmaceutical medicines, vetinary products and orthopaedic products. This is a long-term contract (up to 12 months) and the main purpose of the role is producing Remediation Complaint & Non-Conformities Reports received by Distributors.
Skills required:
? QA Compliance experience, specifically in a medical device regulated environment for FDA
? High understanding and know-how of FDA regulations
? Knowledge of Remediation Minimal Requirement versus Remediation Expanded Requirements
? Able to work autonomously in a Production environment, and independently able to retrieve information needed
? Ability to deliver in accordance to timeframe target of single NCR remediation
? Capacity of delivery facing “limited data available” cases. Pragmatic
? Hands-on role. No management responsibilities.
? Knowledge & experience of using SAP systems for document retrieval
? Good English. German and / or Italian an advantage
? Interview process: Telephone interview only
Urgent position
To apply, call or send your CV to Laura Brum, Recruitment Consultant – RA / QA