Validation & Qualification

Identifying supporting documents, preparation, and approval of necessary documentation during of the first phase. Preparation of validation plans and required protocols, Test Plans and supporting documentation and execution of test activities.

Extended experience in execution and reporting of validation activities (IQ, OQ and PQ) in accordance with standards and customer’s internal instructions and requirements in the final phase.

Examples from earlier projects

Validation of new Device packaging line (Automation & IT)

Preparation of validation protocol & Test Plans and supporting documentation (Process Risk assessment, Rationales, Requirement Classification) and responsible for execution of validation activities (FAT, SAT, IQ & OQ) for the new device packaging lines at Local Manufacturing sites overseas.

Performance Qualification, new device Assembly line

Preparation of Performance Qualification (PQ) protocols, test plans and addressing support documents such as Standard Operation Procedures for a new device- Assembly line.

Required skills: Understanding of the operational processes from ordering a device batch, preparation of the line for production in accordance with a device batch record and to the end of batch with a batch report.

Validation & Qualification, Tablet (Blister Cards) Packaging

Preparation of validation Test Plans and supporting documentation, reviewing supplier documentation such as Design documents, Functional Specifications and test plans and the final verification report. Participation in execution of verification & validation activities (FAT, SAT, IQ/IV, OQ/OV) and responsible for finalization of the verification & validation reports for the new Blister Cards packaging line.

The validation activities have been performed according to “Science- and Risk-based Validation” principals.

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