Represent Quality Assurance throughout the planning, implementation, qualification, and validation phases of the facility project.
Ensure compliance with GMP requirements during the design, installation, and commissioning of manufacturing equipment, utilities, systems, and processes.
Review and approve qualification and validation protocols, reports, procedures, risk assessments, and project documentation.
Support the development and implementation of Quality Management System (QMS) processes and procedures for the new facility.
Participate in Change Control, CAPA, Deviations, investigations, and Quality Risk Management activities.
Collaborate with cross-functional project teams to identify quality risks and implement effective mitigation strategies.
Support inspection readiness activities and contribute to regulatory compliance throughout the project lifecycle.
Work closely with global and local stakeholders to ensure quality standards are successfully integrated into all project phases.
Assist in the preparation of the facility for future internal and external audits and regulatory inspections.

Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Engineering, Chemistry, or a related discipline.
Previous experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, vaccine, or medical device environment.
Solid understanding of GMP principles, quality systems, qualification, validation, and quality risk management.
Experience supporting facility startup projects, equipment implementation, technology transfer, or manufacturing expansion projects is highly desirable.
Strong written and verbal communication skills.
Ability to work effectively in a dynamic, project-oriented environment and collaborate across multiple functions.
Good command of English.

QA Project Specialist

Key skills