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Executive Compliance Consultant Erding Germany,  

PQE (company)


Posted on : 20 February 2017

Project Description


OVERVIEW:
  • Our company is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. 
  • With a network of over 200 dedicated consultants, our company delivers the highest level of expertise to more than 160 customers worldwide.
  •  An international group,our company operates in over forty countries throughout Europe, Asia and the Americas. 
  • Our company offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets. 



JOB DESCRIPTION:
 In this full-time role, the person will be responsible to organize, plan and manage complex 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 managing multidisciplinary teams.



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 10 years  experience in the Pharmaceutical industry (covering managerial or key roles) 
  • Extensive knowledge on the main rules/guidelines/best practices of the major regulated markets (EU and US) 
  • Direct experience in the preparation and hosting of Authority inspections 
  • Suppliers/Vendor management (e.g.: due diligence, qualification audits etc) 
  • Extensive experience in the application of Quality Risk Management and Continuous Improvement 
  • Sufficient expertise on analytics and QC Labs processes 
  • Operational Excellence skills / Lean-Six Sigma certifications (nice to have) 


OTHER SKILLS:
  • Customer management 
  • People management / coaching 
  • Team-play 
  • Project management 
  • Time management 


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


About us:
  • Our collaborators are engaged, developed, challenged and well-rewarded for performance. 
  • We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

Locations

85435 Erding Germany

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