Analista de Garantia da Qualidade Júnior

Myralis; Valinhos; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

Uma empresa farmacêutica está em busca de um Analista para apoiar atividades relacionadas ao ciclo de vida do produto, incluindo a validação de processos e revisão de documentos. O candidato ideal deverá ter formação em áreas relacionadas ao farmaceutico, e conhecimento sobre boas práticas e regulatórios é altamente valorizado. A posição exige comprometimento e habilidades analíticas, com um benefício atrativo e um ambiente dinâmico.

Serviços

Assistência à creche

Bônus de desempenho

Assistência médica

Vale-refeição

Seguro de vida

Vale-transporte

Licença maternidade (180 dias)

Participação nos lucros

Qualificações

• Bacharelado em áreas relevantes (Cursando).
• Experiência na indústria farmacêutica é desejável.
• Conhecimento de GMP e GLP é necessário.

Responsabilidades

• Assistir na gestão e revisão das atividades do ciclo de vida do produto.
• Monitorar desempenho por meio de análises estatísticas.
• Participar de discussões técnicas e revisar documentação.

Conhecimentos

Conhecimento em BPF

Análise estatística

Comunicação técnica

Formação académica

Bacharelado em Farmácia

Engenharia de Produção

Engenharia Química

Engenharia da Computação/Sistemas

Descrição da oferta de emprego

Job Position: Analyst

Required Courses: Bachelor's in Pharmacy, Computer Engineering/Systems, Production Engineering, Chemical Engineering, or related fields (Cursando)

Education Level: Bachelor's Degree in relevant fields (Cursando)

Contract Type: CLT

Work Schedule: Monday to Thursday from 4:45 PM to 1:30 AM, and Friday from 11:00 AM to 7:00 PM

Travel Availability: Yes

Benefits: Childcare assistance, performance bonuses, dental assistance, medical assistance, meal allowance, payroll loan, Gympass, Baby Kit, Maternity Leave (180 days), Profit Sharing, PLR, Cafeteria, Life Insurance, Transportation Voucher

Position Responsibilities

• Assist the focal analyst in planning, defining, managing, elaborating, reviewing, and executing activities related to Phase 3 of the Product Lifecycle: Continued Process Verification (CPV), Periodic Product Review (PPR), and statistical performance evaluations.
• Review and monitor process performance through statistical analysis (charts and discussions) such as normality, capacity, and capability, including technical discussions on analytical results and stability studies for CPV and PPR.
• Support activities related to Phase 1 and Phase 2 of the Product Lifecycle, including Process Validation, Packaging Validation, Holding Time, and Cleaning Validation.
• Monitor pilot batches, performance batches, and industrial-scale batches related to technology transfers and production processes; identify process deficiencies, improvement opportunities, and propose preventive and corrective actions to ensure compliance across all phases.
• Participate in technical discussions, and prepare and review documentation related to process validation, cleaning validation, periodic product review, and continued verification.
• Develop, review, and analyze relevant documentation, perform risk analyses, and review documents for all lifecycle phases.
• Support other Quality Assurance activities such as Change Control, Equipment and Utility Qualification, Computerized Systems, Investigations, Procedures, Training, Audits, among others.

Mandatory Requirements

• Preferably a completed or ongoing Bachelor's degree in Pharmacy, Production Engineering, Chemical Engineering, Computer Engineering/Systems, Chemistry, or related fields.
• Experience in the pharmaceutical industry is desirable.
• Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Knowledge of national and international regulations such as PICs, FDA, ISO, EMA, and GAMP is desirable.