CQV & QA Engineer: Lead Qualification & Compliance

ALTEN; Seixal; Presencial; EUR 44 000 - 56 000; Tempo integral

Resumo da oferta

ALTEN Portugal is seeking a CQV & Quality Assurance Engineer with hands-on experience in reviewing and approving qualification protocols (IQ/OQ/PQ) and ensuring regulatory compliance in highly regulated environments. You will collaborate with engineering and quality teams to align documentation with technical requirements and support audits.

We expect a Bachelor’s or Master’s in Engineering, Life Sciences, Pharmacy, or Biochemistry with at least 2 years in GMP-regulated QA/Qualification.

Qualificações

• Minimum 2 years of QA/Compliance/Qualification or Validation in GMP environments.
• Proven experience reviewing and approving IQ/OQ/PQ protocols and reports.
• Attention to detail with strong traceability between requirements, testing and documentation.

Responsabilidades

• Develop, review, and approve qualification protocols (IQ, OQ, PQ) and reports to ensure regulatory standards are met.
• Collaborate with engineering teams to align documentation with technical requirements and project objectives.
• Ensure traceability between requirements, testing, and validation deliverables.
• Review design specs, test scripts, and SOPs for accuracy and compliance.
• Approve deviations, change controls, and CAPAs related to qualification activities.
• Provide QA oversight during testing and validation phases to ensure compliance and quality.
• Support audits and inspections by providing documentation to regulatory bodies.

Conhecimentos

IQ/OQ/PQ

Quality Assurance

Regulatory compliance

Traceability

Deviation management

CAPA

Audits & inspections

Formação académica

Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, Biochemistry

Descrição da oferta de emprego

ALTEN Portugal is seeking a CQV & Quality Assurance Engineer with hands-on experience in reviewing and approving qualification protocols (IQ/OQ/PQ) and ensuring regulatory compliance in highly regulated environments. You will collaborate with engineering and quality teams to align documentation with technical requirements and support audits.

We expect a Bachelor’s or Master’s in Engineering, Life Sciences, Pharmacy, or Biochemistry with at least 2 years in GMP-regulated QA/Qualification.