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Technical Qualification Project Manager - Italy  

PQE (company)


Posted on : 20 February 2017

Project Description

  •  Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports 
  •  Development of installation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP) 
  •  Development of thermal validation study protocols 
  •  Development of project validation master plans for new sites implementation including detailed Gantt charts with predecessors and resources workload evaluation (advanced knowledge of Microsoft Project requested) 
  •  Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments) 
  •  Coordination of junior resources for qualification testing execution and use of test instruments  
  •  Development of risk based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP) 
  •  Development of calibration and maintenance plans and related instructions 
  •  Development of standard operating procedures 
  •  Advanced knowledge of EU and US GMP 

  • Fluent English (Mandatory) 
  • Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics) 
  • Minimum of 3 years’ experience in the drug manufacturing area 
  • Aptitude for travel (Mandatory) 
  • Integrity, strong analytical skills and attention to detail 

Nice to have:
  •  Fluent in other languages 
  •  PhD in technical fields 

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.
  •  The availability to travel is required.