Mf01-103124 Quality Specialist

1 semana atrás

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:

- Quality Specialist - CAPA Implementation

Qualifications:

- Bachelor's Degree in Engineering or Science Field
- 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 with CAPA processes.
- Knowledge of systems such as: Windchill, Ecapa, MES, or BMRAM.
- Experience in risk management and line clearance.
- Experience with change assessments, process validations, ESQ and software validations.
- Previous experience with quality assurance (required).
- Available to work extended hours, possibility of weekends and holidays.

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