Technical Qualification Project Manager - Italy
- 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
- 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.