QA (Senior) CQV Specialist

Lonza

Geleen, Netherlands

Are you an experienced professional with a keen eye for quality and documentation? We are looking for QA (Senior) CQV Specialist who plays a crucial role in ensuring the highest standards within our organization. It is important to note that this role is not focused on operational execution. We are seeking QA candidates who are not involved in technical execution.

At Lonza, the engineers execute the qualification tests, while the QA professional is responsible for reviewing and approving protocols and tests. The QA person does not execute the qualifications. Instead, you will focus on reviewing and approving protocols and documentation related to the qualification and validation of equipment, facilities, and utilities. You will ensure that all validation documents and procedures, including those for operations, cleaning, and maintenance, are appropriately documented. When deviations occur, you will be involved in ensuring that all necessary corrective actions and systemic solutions are properly implemented.

What you will do:

Review and approve: User Requirement Specifications (URS), qualification and validation plans, validation documentation (DQ, IQ, OQ, PQ) and risk assessments related to for equipment, facilities, and utilities
Coordinate commissioning protocols and reports
Review and approve FAT/SAT documentation and Validation Life Cycle Documentation
Ensure accurate application of validation quality systems and develop improvement plans
Conduct periodic reviews of validated GxP equipment, facilities, and utilities
Quality oversight on validation impact assessments prior to changes on equipment, facilities, or utilities
Provide support for quality-related issues, including GMP regulations and internal SOP compliance
Assist production and technical service teams with validation activities
Manage validation deviations and CAPA processes
Contribute to continuous improvement and international standardization

What you will bring:

Bachelor's degree in a scientific or technical field (minimum)
Minimum 1-3 year of experience in validation activities within a pharmaceutical or biotech manufacturing environment
Quality assurance experience with a focus on technical installations (facility/utility)
Expertise in HVAC, autoclave, VHP, purified water, and process gases
Experience with laboratory systems in a pharma environment
Understanding of regulatory requirements and industry standards (FDA, EMA, ICH, etc.)
No company visa sponsorship available for this role

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