Technical Qualification Consultant

hace 2 semanas


Buenos Aires, Argentina PQE Group A tiempo completo
We are a
service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998.

With more than 1500 employees, 45+ nationalities and
29 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
Consultant to implement our team in
Buenos Aires, Argentina.


In this full-time role, the TQ Senior Consultant will participate in Technical Qualification & Engineering projects for clients in the Pharmaceutical and Medical Devices Industries.

The Senior 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 qualification 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)

  • Exprience in Development of
    calibration and maintenance plans and related instructions

REQUIREMENTS:

-
Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics etc.)
-
+5 years' 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
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.


Tipo de puesto:
Tiempo completo

Salario:
$1,00 - $10,00 al mes

Idioma:

  • Inglés (Obligatorio)

Disponibilidad para viajar:

  • 75 % (Obligatorio)


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