Quality Assurance System Specialist

Labatec Pharma; Lisboa; Presencial; EUR 45 000 - 65 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Ambiente colaborativo

Formação profissional contínua

Remuneração e benefícios

Resumo da oferta

A Labatec Pharma, empresa farmacêutica suíça com atuação global, procura um(a) Especialista em Sistemas de Garantia de Qualidade para integrar a sua equipa de QA. Será responsável por manter e melhorar o PQS para cumprir GMP e regulatórios, supervisionando SOPs, QMS e CAPA.

Requer-se licenciatura ou mestrado em Farmácia ou áreas relacionadas, 3–5 anos de experiência em QA farmacêutica e conhecimento de QMS/eQMS.

Qualificações

• Experiência em QA na indústria farmacêutica com GMP.
• Conhecimento de requisitos EU-GMP e PQS.
• Experiência com gestão de documentos e ciclos de vida de SOPs.

Responsabilidades

• Gerir o ciclo de vida de SOPs, políticas e documentos de qualidade.
• Supervisionar formação GMP/qualidade e assegurar treino adequado da equipa.
• Conduzir auditorias internas e seguir CAPA.
• Gerir alterações com avaliação de risco e impacto regulatório.
• Analisar desvios, realizar investigações e eficácia de CAPA.
• Utilizar ferramentas de avaliação de risco e integrar QRM.
• Estabelecer KPIs de qualidade e reportar tendências à gestão.
• Gerir QMS eletrónico e melhorias de sistema.

Conhecimentos

Conhecimento GMP/GQP

Análise de risco

Gestão de QMS/eQMS

Capacidade de auditorias internas

Análise de CAPA e desvios

Excel avançado

Trabalho com cross-funtional teams

Comunicação eficaz

Formação académica

Licenciatura/Mestrado em Farmácia ou ciências químicas

Ferramentas

QMS/eQMS

Descrição da oferta de emprego

Descrição do cargo

Valuing People. Science. Life - At Labatec Pharma, we are committed to deliver medicines that help to improve quality of life for patients around the world by meeting the needs of the hospital and retail sectors. We collaborate all together to deliver outcomes which add significant value to our clients’ projects and the community as a whole. Our people are at the center of Labatec Pharma.

Labatec is looking for talented individuals to join its growing team! Join us!

We are currently looking for a Quality Assurance System Specialist to join our QA team. The Quality Assurance System is mainly responsible for maintaining, overseeing, and continuously improving the Pharmaceutical Quality System (PQS) to ensure that the company operates in compliance with GMP, regulatory requirements, and internal procedures.

Your key responsibilities:

• Manage the lifecycle of SOPs, policies, forms and quality documents; ensure periodic review and document control;
• Manage GMP/quality training systems and ensure personnel are appropriately trained before performing activities;
• Conduct Internal Audits (Conduct regular self-inspections to the different GxP areas and periodically following-up CAPA plan);
• Ensure changes are appropriately assessed for quality/regulatory impact, approved, implemented and closed;
• Oversee deviation processes, complete investigation quality, root-cause analysis and CAPA effectiveness;
• Ensure appropriate use of risk assessment tools and integration of QRM into quality processes;
• Establishand monitor quality KPIs, trends and periodic reporting to management;
• Manage/oversee electronic QMS and related quality systems, including workflows, access, data integrity and system improvements.

Act as a catalyst for continuous improvement and promote the importance of high Quality and Integrity standards;

We are looking for:

Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, Engineering or a related scientific field.

3–5 years of experience in Quality Assurance within the pharmaceutical industry, preferably in a GMP manufacturing environment.

Strong knowledge of EU GMP/GMP requirements and pharmaceutical quality systems.

Experience with Quality Management Systems (QMS/PQS) and electronic quality management systems (eQMS).

Practical experience managing or supporting deviations, CAPA, change controls and quality risk assessments.

Experience with SOP and document management, including document lifecycle and periodic review.

Experience supporting internal, supplier and regulatory audits/inspections.

Good understanding of root cause analysis and investigation methodologies.

Experience with quality metrics, trending and identification of recurring/systemic quality issues.

Good understanding of GMP training systems and training compliance.

Experience in continuous improvement and quality system enhancement.

Ability to work effectively with cross-functional teams, including Production, QC, Engineering, Supply Chain and Regulatory Affairs.

Strong analytical, organisational and problem-solving skills.

Ability to challenge processes constructively and make risk-based quality decisions.

Excellent written and verbal communication skills.

Fluent English; Frensch is an advantage.

Proficient in Microsoft Office, particularly Word and Excel; experience with electronic QMS platforms is an advantage.

Detail-oriented

Proactive and accountable

Structured and organised

Analytical and critical minded

Pragmatic and solution-oriented

Comfortable working in a fast-paced and changing environment

We will offer you

• A collaborative and friendly environment within a human-size company
• An established Company operating with agility
• Continuous professional training to develop your potential
• A rewarding compensation & benefits package

About us

Labatec is a Swiss-based private pharmaceutical company, headquartered in Geneva, Switzerland. Our company has 60+ years experience in the production and supply of medicines to 11 countries comprising Switzerland, the Middle East and North Africa and expanding today in Europe. We aim to be a leading licensing partner in generic and specialty innovative medicines in our markets with an extensive portfolio of 70+ products in both the retail and hospital segments. We serve our communities by developing, manufacturing, and distributing high quality medicines covering major therapeutic areas such as musculo-skeletal, ophthalmology, anaesthetics, oncology, anti-infectives and women’s health.

For more information, please visit our website: http://www.Labatecpharma.Com/about-us/