Rome, Florence, Milan
Technical Qualification Consultant
We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 900 employees all over the world (Europe, Asia and the Americas) and 25 subsidiaries, joining PQE means join a multicultural and challenging company in which you will be not only involved in international projects but you'll also have the chance to get in touch with colleagues from all over the world.
Due to a constant growth, PQE is looking for a new Technical Qualification Consultant.
- 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
Core Responsibilities include, but are not limited to the following:
- Technical Degree (Engineering, Chemistry, Biotechnology, Informatics, Physics, Mathematics)
- +2 years of experience in the Equipment and Installation Qualification of drug manufacturing area (Life Science / Pharmaceutical Sector)
- English: Fluent
- Integrity, strong ethics, analytical skills and attention to details
If interested, please send your resume clicking the "APPLY NOW" button on this page.
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.