São Paulo, Brazil
Technical Qualification Consultant
Due to a constant growth, PQE Brazil is looking for a new Technical Qualification Consultant expert in facilities, process equipment, utilities and related control systems qualification in the regulated pharmaceutical and medical devices environments.
- 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)
- 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
Responsibilities include, but are not limited to, the following:
- Fluent English
- Full availability to travel
- Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
- Minimum of 3 years’ experience in the same role
- Integrity, strong analytical skills and attention to details
If interested, please send your resume in English If interested, please send your resume in English, clicking 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.