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).
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.
Bachelor’s degree in scientific or technical field (minimum)
Minimum 1 year of experience in validation activities in a pharmaceutical or biotech manufacturing environment
Quality assurance experience
Experience in QA activities with a strong focus on technical installations (facility/utility)
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.)
