Ll01-041524 Validation Specialist

Há 7 dias

Paraná, Brasil Validation & Engineering Group Tempo inteiro

**_Validation & Engineering Group, Inc. _**(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

- **Validation Specialist (Temperature Mapping Project)**

Qualifications:

- Bachelor's Degree in Science or Engineering.
- Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- **Experience in Temperature Mapping is a must.**:

- Design Documentation (URS, DS), FQ, IQ, OQ, PQ protocols development and execution, deviations and reports generation.
- SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
- Strong knowledge (according to related area).
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.

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