QA Systems Lead: GMP & Compliance Champion

Labatec Pharma SA

Viseu

Presencial

EUR 40 000 - 60 000

Tempo integral

há 44 horas
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Resumo da oferta

Labatec Pharma SA is seeking a Quality Assurance System Specialist to join its QA team. The role focuses on maintaining the Pharmaceutical Quality System (PQS) to ensure GMP compliance and drive continuous improvement across quality processes.

You will manage SOPs, document control, GMP training, internal audits, change controls, CAPA, risk assessments and KPI reporting, while overseeing electronic QMS platforms and data integrity in a fast-paced environment.

Qualificações

  • Degree in Pharmacy, Pharmaceutical Sciences, Chemistry or related field.
  • 3–5 years in Quality Assurance within pharma, GMP environment preferred.
  • Strong knowledge of EU GMP and QA systems.
  • Experience with QMS/PQS and electronic QA platforms.
  • Experience in deviations, CAPA, change controls and risk assessments.
  • Audits and inspections experience; document lifecycle management.
  • Good English; French is a plus.

Responsabilidades

  • Manage SOPs, policies, forms and quality documents lifecycle.
  • Ensure periodic review, document control and training systems.
  • Oversee GMP/quality training and staff readiness.
  • Conduct internal audits and CAPA follow-ups.
  • Assess quality/regulatory impact of changes; close actions.
  • Oversee deviation handling, root-cause analysis and CAPA effectiveness.
  • Utilize risk tools and integrate QRM into processes.
  • Establish/monitor KPIs and report to management.
  • Manage electronic QMS workflows, access and data integrity.

Conhecimentos

Quality mindset
Cross-functional collaboration
Analytical thinking
Problem-solving
Documentation control
Communication skills
Attention to detail
Training and coaching

Formação académica

Bachelor's or Master's degree in Pharmacy or related scientific field

Ferramentas

eQMS platforms
Microsoft Word
Microsoft Excel

Descrição da oferta de emprego

Labatec Pharma SA is seeking a Quality Assurance System Specialist to join its QA team. The role focuses on maintaining the Pharmaceutical Quality System (PQS) to ensure GMP compliance and drive continuous improvement across quality processes.

You will manage SOPs, document control, GMP training, internal audits, change controls, CAPA, risk assessments and KPI reporting, while overseeing electronic QMS platforms and data integrity in a fast-paced environment.

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