Beschreibung
For one of our Swiss Pharma Biotech clients we are seeking freelance support as:Commissioning Verificiation & Qualification Execution Lead (M/F)
Tasks:
Leading and coordinating a verification/qualification program, incorporating black utilities, clean utilities, HVAC and cleanrooms, upstream and downstream processing, including CIP and SIP
Generation of CVQ change controls and drive their timely closure
Maintenance of a clean and safe working environment by enforcing procedures, policies, and regulations
Generation of method statements, risk assessments and permit preparation for responsible areas to handover to end users
Assisting in investigations of process equipment, utility systems, and control systems, as well as safety incidents
Implementation of CVQ strategies as set out by the head CVQ
Qualification:
BSc/MSc in engineering, biotech and/or pharma process
Profound experience in commissioning/qualification of USP/DSP facilities, including all utilities (black and clean) within the pharmaceutical/biotech industry
Technical knowledge of utilities, USP, DSP equipment, biotech processes, CIP/SIP
Working knowledge of Swissmedic, EU and FDA regulations
Knowledge of regulations and standards affecting biotech products
Must Have: Business fluency in German and English
Requirements:
Start: asap, latest 15.02.2019
Duration: 12 months
Capacity: 4 days must, ideally 5 days / week