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.
Responsibilities include, but are not limited to, the following :
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
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.
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