Job Location:
São Paulo, Brazil
Technical Qualification Consultant
Requested Languages:
OR
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
REQUIREMENTS:
Full-Time Job
If interested, please send your resume in English If interested, please send your resume in English, clicking on this page.
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