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Pharma Compliance Consultant - Germany  

PQE (company)


Posted on : 20 February 2017

Project Description


Description:
In this full-time role, the person will be responsible to work in different projects related to Pharma Quality Compliance such as authority inspection preparation and/or remediation or quality improvement initiatives. The person will work alone or more frequently among multidisciplinary teams and he/she will be coordinated by appropriate senior roles


MAIN AREA OF EXPERTISE:
  •  API manufacturing (including high potent compounds) 
  •  Finished Product manufacturing 
  •  Sterile productions (both APIs and FPs) 
  •  Excipient manufacturing 
  •  Pharma distribution (APIs and FPs) 


KEY COMPETENCES:
  •  Technical Degree (Pharmacy, Pharmaceutical Chemistry, Microbiology, Chemistry, Engineering) 
  •  Minimum of 3 years  experience in the Pharmaceutical industry (covering managerial or key roles) 
  •  Basic knowledge on the main rules/guidelines/best practices of the major regulated markets (EU and US) 
  •  Suppliers/Vendor management (e.g.: qualification audits, monitoring etc) 
  •  Basic knowledge on Quality Risk Management and Continuous Improvement 
  •  Basic expertise on analytics and QC Labs processes 
  •  Experience in the preparation and hosting of Authority inspections (nice to have) 
  •  Operational Excellence skills / Lean-Six Sigma certifications (nice to have) 


OTHER SKILLS:
  •  Team-play 
  •  Project management (nice to have) 
  •  Time management (nice to have) 
  •  Customer management (nice to have) 


LANGUAGES:
  •  English (fluent): mandatory 
  •  German (fluent): mandatory 
  •  French: nice to have 
  •  Spanish: nice to have 



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