![PQE Group](https://media.trabajo.org/img/noimg.jpg)
Technical Qualification Consultant
hace 2 semanas
service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998.
With more than 1500 employees, 45+ nationalities and
30 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a
multicultural and challenging company with many
local and international projects, and colleagues from all over the world.
Due to our constant growth, we are looking for a
Validation Consultant to implement our team in
Buenos Aires, Argentina.
In this full-time role, the TQ Consultant will participate in Technical Qualification & Engineering projects for clients in the Pharmaceutical and Medical Devices Industries.
The Consultant will work alone or more frequently as part of multidisciplinary teams (either as leader or team member), depending on the nature and complexity of the project.
- Capable of develop of qualification documents, user/technical requirements specifications, design qualification reports, test plans, requirementstesting traceability matrixes, qualification summary reports
- Experience in the 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)
- Experience in the
development of validation documents for computerized system, including plan, user requirements and other specification documents, test protocols, traceability matrix and reporting - Knowledge of the main
test instruments suites (e
g:
GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)
- Experience in the riskbased assessment at process, component and functional level according to the internationally recognized methodologies (e
g:
FMEA, HACCP)
- Experience in Development of calibration and maintenance plans and related instructions
- Execution of IQ, OQ and PQ protocols including Thermal validation study, water, steam systems and HVAC.
REQUIREMENTS:
-
Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics etc.)
-
Experience in the Pharmaceutical drug manufacturing area -
Equipment and Utility validation:
-
Fluent English:
- Integrity, strong analytical skills and attention to details
Availability to travel domestically and internationally
- Advanced
knowledge of local
GMPs
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.
Tipo de puesto:
Tiempo completo
Salario:
$1,00 - $10,00 al mes
Idioma:
- Inglés (Obligatorio)
Disponibilidad para viajar:
- 75 % (Obligatorio)
-
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