Société Générale de Surveillance

Testing, inspection, and certification services globally

Qualification & CSV Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

ContractLisbon, PortugalNo salary listed

About the Job

Requirements

A Licenciatura or Master's degree in Engineering, Pharmaceutical Sciences, Biotechnology, or a similar field.
At least 2 years of experience in Qualification & Validation and/or CSV.
Knowledge of GMP/GxP, GAMP 5, and Annex 11.
Experience preparing validation documentation.
Fluent English.
Availability to travel.

Responsibilities

Execute qualification activities for equipment, facilities, utilities, and systems.
Prepare, execute, and review DQ, IQ, OQ, and PQ protocols.
Develop and execute CSV activities in accordance with GAMP 5 and GMP.
Prepare technical validation documentation, including URS, Risk Assessments, Validation Plans, Test Scripts, and Reports.
Participate in projects implementing and validating equipment and computerized systems.
Support Change Controls, CAPAs, deviations, and investigations.
Collaborate with multidisciplinary teams and have direct contact with clients.

Desired Qualifications

Technical rigor and attention to detail.
Analytical and problem-solving ability.
Organization, autonomy, and priority management.
Communication and interpersonal skills.
Customer and results orientation.

Descrição do emprego

A SGS procura um(a) Qualification & Validation & CSV Specialist (Freelancer) para colaborar em projetos na indústria farmacêutica, biotecnológica e de dispositivos médicos, assegurando atividades de qualificação, validação e conformidade com os requisitos GxP/GMP e regulamentação aplicável.

Principais responsabilidades:

Execução de atividades de qualificação de equipamentos, instalações, utilidades e sistemas.
Elaboração, execução e revisão de protocolos DQ, IQ, OQ e PQ.
Desenvolvimento e execução de atividades de CSV de acordo com GAMP 5 e GMP.
Preparação de documentação técnica de validação (URS, Risk Assessments, Validation Plans, Test Scripts e Reports).
Participação em projetos de implementação e validação de equipamentos e sistemas computorizados.
Apoio em Change Controls, CAPAs, desvios e investigações.
Colaboração com equipas multidisciplinares e contacto direto com clientes

Qualificações

Licenciatura/Mestrado em Engenharia, Ciências Farmacêuticas, Biotecnologia ou área similar.
Experiência mínima de 2 anos em Qualification & Validation e/ou CSV.
Conhecimentos de GMP/GxP, GAMP 5 e Annex 11.
Experiência na elaboração de documentação de validação.
Inglês fluente.
Disponibilidade para deslocações.

Informação adicional

Competências valorizadas:

Rigor técnico e atenção ao detalhe.
Capacidade analítica e de resolução de problemas.
Organização, autonomia e gestão de prioridades.
Excelentes competências de comunicação e relacionamento interpessoal.
Orientação para o cliente e para resultados.

About the Company

Société Générale de Surveillance

Testing, inspection, and certification services globally

SGS provides testing, inspection, and certification services to help clients meet regulations, ensure quality and safety, and gain market access. It runs laboratory testing, on-site inspections, and certification against standards, often with training and consulting, across a wide range of industries. The services rely on a global network of laboratories and offices that deliver localized solutions with global expertise. What sets SGS apart is its large global footprint and its emphasis on quality, integrity, risk mitigation, and sustainability, enabling it to serve a diverse set of customers from small businesses to multinationals. The company's goal is to help customers comply with regulations, improve product quality and safety, reduce risk, and boost productivity across markets.

Company size: 10,001+
Company stage: IPO
Headquarters: Geneva, Switzerland
Founded: 1878

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