Quality Assurance Engineer

ALTEN; Lisboa; Presencial; EUR 42 000 - 62 000; Tempo integral

Resumo da oferta

ALTEN Portugal, a leading force in IT, Engineering and Life Sciences, seeks a dedicated Quality Assurance Engineer with hands-on experience in reviewing and approving IQ/OQ/PQ and ensuring regulatory compliance.

In this role, you will work with engineering and quality teams to align documentation with requirements, support audits, manage deviations and CAPA, and drive continuous improvement in qualification processes.

Qualificações

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, Biochemistry, or related field.
• Minimum of 2 years of relevant GMP-regulated QA/Validation experience.
• Proven experience reviewing and approving IQ/OQ/PQ protocols and reports.
• Familiarity with deviation management, change control, and CAPA processes.
• Attention to detail and traceability between requirements, testing, and documentation.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication.
• Proactive mindset with continuous improvement focus.

Responsabilidades

• Develop, review, and approve qualification protocols (IQ, OQ, PQ) and related reports.
• Collaborate with engineering to align documentation with requirements.
• Ensure traceability between requirements, testing, and validation deliverables.
• Review designs, test scripts, and SOPs for accuracy and compliance.
• Approve deviations, change controls, and CAPAs related to qualification activities.
• Support audits and inspections with documentation and clarifications.
• Stay updated on regulatory changes affecting qualification and validation processes.
• Provide QA oversight during testing and validation.

Conhecimentos

Attention to detail

Analytical thinking

Communication skills

Proactive mindset

Formação académica

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

Descrição da oferta de emprego

ALTEN Portugal, a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and detail-oriented Quality Assurance Engineer with hands-on experience in reviewing and approving qualification protocols (IQ/OQ/PQ) and ensuring regulatory compliance in highly regulated environments.

ALTEN Group

Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 54,000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.

Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?

In this role, you will collaborate closely with engineering and quality teams to align documentation with technical requirements, support audits and inspections, and drive continuous improvement in qualification processes. Your expertise in traceability, deviation management, and CAPA will be critical to maintaining the highest standards of quality assurance and regulatory adherence.

Key Responsibilities:

• 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.

Qualifications:

• 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 (e.g., pharmaceuticals, biotechnology, medical devices).
• 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.

Location: Presential, Lisbon.

Why Join Us?

• Possibility to work with cutting-edge technology in the Life Sciences industry
• Collaborative and dynamic work environment
• Possibility to join a top-leading company in the industry
• Possibility to join different and interesting projects