Support in Validation & Qualification

Description:

As part of the site modernization program, the resource will report and provide support to the local lab project lead.

He/She will be responsible for the validation & qualification activities of Quality & Lab systems including data integrity.

The scope includes lab systems, computer systems and equipment’s linked to pharmaceutical manufacturing.

All of this in accordance with our company standard processes and compliance rules.

Areas of responsibilities are:

- Participating in continuous improvement processes for Quality&Lab systems

- Creation of validation lifecycle documents according to the Organon standards

- Testing of Quality / Lab systems

- Execution of validation test protocols

- Creation of retirement protocols

- Creation of Standard Operating Procedures

- Support operations/production at startup of project

Knowledge of:

- Quality and Laboratory processes

- System Validation Lifecycle

- Pharmaceutical Industry and Standards (GDP, GxP)

- Dutch/English (Verbal/Written)