Quality Computerized Systems Specialist - LISBOA

Descrição: 

We are currently recruiting a QA Tester for a multinational pharmaceutical company with worldwide operations.

O que terás de fazer

- Apply and develop knowledge of Quality’s Computerized Systems;

- Support the evaluation of design documents against regulatory and company compliance requirements;

- Apply a risk-based approach throughout the life cycle of the Computerized Systems;

- Understand and apply policies for Computerized Systems life cycle management;

- Participate as part of multi disciplinary work groups with Quality Assurance;

- Issue/prepare/review protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Qualification of Computerized Systems;

- Support in reviewing Computerized System change controls, deviations, incidents submitted by any Department/Site;

- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements;

O que precisas de garantir

- University, or equivalent, qualification in Chemistry, Chemical Engineering or similar scientific field (mandatory)

- Requires educational / training experience in Computerized Systems Validation

- Knowledge of:

• Software testing

• Quality systems and validation principles

• Computerized Systems Validation

• Risk Assessment applied to Computerized Systems Life Cycle

- Fluency in English is a requirement

O que te proporcionamos

Annual bonus

Health insurance for you and your family

Life insurance

Technical trainning

O que terás de fazer

- Apply and develop knowledge of Quality’s Computerized Systems;

- Support the evaluation of design documents against regulatory and company compliance requirements;

- Apply a risk-based approach throughout the life cycle of the Computerized Systems;

- Understand and apply policies for Computerized Systems life cycle management;

- Participate as part of multi disciplinary work groups with Quality Assurance;

- Issue/prepare/review protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Qualification of Computerized Systems;

- Support in reviewing Computerized System change controls, deviations, incidents submitted by any Department/Site;

- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements;

O que precisas de garantir

- University, or equivalent, qualification in Chemistry, Chemical Engineering or similar scientific field (mandatory)

- Requires educational / training experience in Computerized Systems Validation

- Knowledge of:

• Software testing

• Quality systems and validation principles

• Computerized Systems Validation

• Risk Assessment applied to Computerized Systems Life Cycle

- Fluency in English is a requirement

O que te proporcionamos

Annual bonus

Health insurance for you and your family

Life insurance

Technical trainning