Quality Assurance System Lead – GMP, eQMS & CAPA

Labatec Pharma SA; Sintra; Presencial; EUR 40 000 - 60 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Collaborative environment

Continuous professional training

Competitive compensation & benefits

Resumo da oferta

Labatec Pharma SA in Portugal is seeking a Quality Assurance System Specialist to join its QA team. The role focuses on maintaining and improving the Pharmaceutical Quality System to ensure GMP compliance and regulatory adherence.

You will manage SOPs, QMS/eQMS, CAPA, deviations, risk assessments, and KPIs while collaborating with Production, Regulatory Affairs, and Engineering to drive continuous improvement.

Qualificações

• 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.

Responsabilidades

• 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; self-inspections to GxP areas and CAPA follow-ups.
• Ensure changes are assessed for quality/regulatory impact and implemented.
• Oversee deviation processes, investigations, root-cause analysis and CAPA effectiveness.
• Establish and monitor quality KPIs and reporting to management.
• Manage electronic QMS and related systems, data integrity and improvements.

Conhecimentos

Quality mindset

Analytical thinking

Cross-functional teamwork

Problem-solving

Documentation

Communication skills

Risk assessment

Attention to detail

Formação académica

Bachelor’s or Master’s degree in Pharmacy or related field

Ferramentas

QMS/PQS software

Excel

Word

eQMS platforms

Descrição da oferta de emprego

Labatec Pharma SA in Portugal is seeking a Quality Assurance System Specialist to join its QA team. The role focuses on maintaining and improving the Pharmaceutical Quality System to ensure GMP compliance and regulatory adherence.

You will manage SOPs, QMS/eQMS, CAPA, deviations, risk assessments, and KPIs while collaborating with Production, Regulatory Affairs, and Engineering to drive continuous improvement.