QA Validation Specialist

QA Validation Specialist

Lonza

Geleen, Netherlands

QA Validation Specialist reviews and approves documentation and oversees qualification and validation deliverables, associated with equipment, facility and utilities. He/she reviews and approves validation documents and procedures associated with equipment, facility and utility operation, cleaning and maintenance. He/she assures the deviations and changes are well documented and applicable corrective actions and systemic solutions are applied.

Key responsibilities:

• Overseeing validation and qualification deliverables:
• Review and approve URSs;
• Review and approve qualification and validation plans;
• Review and approve validation documentation associated with equipment, facilities and utilities (DQ, IQ, OQ, PQ);
• Review and approve the risk assessment related to equipment, facilities and utilities;
• Review and approve the commissioning protocols and reports;
• Review and approve FAT/SAT documentation;
• Assure requirements traceability throughout the whole project validation file (from URS to PQ).

Overseeing validation life cycle documentation:

• Review and approve equipment, facility and utility life cycle documents;
• Ensure the correct application of the validation quality systems on the field and to define improvement plan;
• Understanding of cGMPs, GAMP, ICH Q7A and validation practices (IQ/OQ/PQ) and their application in practice;
• Conducting periodic review of validated GxP equipment, facility and utilities;
• Performing validation impact assessments prior to implementation of changes on equipment, facility or utilities;
• Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable and consistent operation of the system;
• Support the production & technical services teams in the implementation of the validation activities;
• Ensure the adequate management of validation deviations (be QA GMP Responsible) and potentials CAPA (be Compliance Authority);
• Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

Key requirements:

• Bachelor’s degree in scientific or technical field (minimum);
• Minimum 1 year of experience in validation activities in a pharmaceutical or biotech manufacturing environment (preferable);
• Quality assurance experience;
• LAB commissioning qualification and validation experience;
• expertise in the area of HVAC/autoclave/VHP/purified water/process gasses;
• Experience with laboratory systems in pharma environment;
• Understanding of regulatory requirements and industry standards (FDA, EMA, ICH, etc.).

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