CQV & QA Engineer

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, a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and detail-oriented 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.

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.

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