Technical Qualification Consultant

hace 6 días

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, requirements-testing 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 risk-based 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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