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Pharma Compliance Consultant (German Speaking) Erding 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 (native): mandatory  
  • French: nice to have  
  • Spanish: nice to have  

Locations

85435 Erding Germany

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