CQV & QA Engineer: GMP Compliance & IQ/OQ/PQ

ALTEN; Seixal; Presencial; EUR 40 000 - 55 000; Tempo integral

Resumo da oferta

ALTEN Portugal is seeking a CQV & Quality Assurance Engineer with hands-on experience in reviewing and approving IQ/OQ/PQ and ensuring regulatory compliance in GMP-regulated environments. You will collaborate with engineering and quality teams to align documentation with requirements, support audits and inspections, and drive continuous improvement in qualification processes.

This role emphasizes traceability, deviation management and CAPA, with proactive communication and a focus on quality

Qualificações

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, Biochemistry, or a related field.
• Minimum of 2 years of relevant experience in Quality Assurance, Compliance, Qualification or Validation within GMP‑regulated environments.
• Proven experience reviewing, and approving qualification protocols (IQ/OQ/PQ) and reports.
• Familiarity with deviation management, change control, and CAPA processes.
• Attention to detail and ability to ensure traceability between requirements, testing, and documentation.
• Strong analytical and problem‑solving skills to identify gaps and propose solutions.
• Excellent written and verbal communication skills for collaborating with cross‑functional teams.
• Proactive mindset with a focus on continuous improvement and adherence to best practices.

Responsabilidades

• Develop, review, and approve qualification protocols (IQ, OQ, PQ) and reports to ensure compliance with regulatory standards (e.g., GMP, FDA, EMA, ISO).
• Collaborate with engineering teams to align documentation with technical requirements and project objectives.
• Ensure traceability between requirements, testing, and validation deliverables.
• Review engineering documents, including design specifications, test scripts, and SOPs, for accuracy and compliance.
• Approve deviations, change controls, and CAPAs related to qualification activities.
• Ensure all documentation meets regulatory and internal quality standards.
• Ensure all qualification activities adhere to applicable regulations and guidelines (e.g., GMP, FDA, EMA, ISO).
• Support audits and inspections by providing documentation and clarifications to regulatory bodies.
• Stay updated on industry trends and regulatory changes affecting qualification and validation processes.
• Work closely with engineering, operations, and quality teams to align on project timelines and deliverables.
• Provide QA oversight during testing and validation phases to ensure compliance and quality.
• Escalate issues or gaps in documentation or processes to stakeholders for resolution.
• Identify opportunities to streamline qualification processes and improve efficiency.
• Participate in lessons‑learned sessions and implement best practices to enhance quality and compliance.
• Contribute to the development of standardized procedures and tools for qualification activities.

Conhecimentos

Attention to detail

Analytical thinking

Communication skills

Continuous improvement

Formação académica

Bachelor's or Master's degree in Engineering/Life Sciences/Biochemistry

Descrição da oferta de emprego

ALTEN Portugal is seeking a CQV & Quality Assurance Engineer with hands-on experience in reviewing and approving IQ/OQ/PQ and ensuring regulatory compliance in GMP-regulated environments. You will collaborate with engineering and quality teams to align documentation with requirements, support audits and inspections, and drive continuous improvement in qualification processes.

This role emphasizes traceability, deviation management and CAPA, with proactive communication and a focus on quality