As a QA Qualification/Validation Contractor, you will be responsible for ensuring that all regulatory and procedural requirements related to Qualification/Validation are met throughout the entire lifecycle of systems and processes. This includes the concept, project, operational, and retirement phases.
Your key responsibilities will be to:
Review and approve qualification/validation documents and quality records, such as SOPs, user requirements, risk analyses, test plans, test scripts, change controls, and CAPAs, to ensure compliance with regulations and guidelines.
Collaborate with engineering teams and other departments on the introduction of new or upgraded systems and processes, providing expert advice and support to safeguard cGMP aspects.
Address and follow up on deviations that occur during the execution of qualification/validation activities.
Communicate the status of quality, compliance, and project planning to the QA qualification/validation team.
Multiple profiles are needed for this project, with opportunities in the following areas:
Manufacturing Systems Qualification
Laboratory Systems Qualification
Facility and Utility Systems Qualification
IT/Automation systems Computer System Validation
