For a pharmaceutical company focused on the development and production of a wide range of medicines and vaccines, with a specific focus on chronic and complex conditions, we are seeking a Qualification and Validation engineer.
Key Responsibilities:
* Validation Execution: You will perform a full range of validation activities, including developing User Requirement Specifications (URS), conducting System Impact Assessments (SIA), and carrying out the Design (DQ), Installation (IQ), Operational (OQ), and Performance (PQ) Qualifications. This is a hands-on role where you will be directly involved in the process.
* System Qualification: You will qualify systems by interpreting and applying established industry standards to specific cases, ensuring full compliance with cGMP and Good Laboratory Practices (cGLP).
* Documentation and Change Control: You are responsible for all validation documentation, from drafting to final approval. You will also review and assess any proposed changes to systems to determine their impact on the validated status.
* Compliance & Technical Expertise: You will ensure that the qualified status of all systems is maintained in compliance with cGMP at all times. You will also stay current with emerging FDA and EU regulations and provide technical assistance on these requirements.
* Project Support: You will support projects by ensuring all validation activities adhere to required regulatory standards and internal company procedures.
Requirements:
* Knowledge of CGMP requirements in a regulated environment.
* Understanding of relevant quality and compliance regulations.
* Capable of troubleshooting validation issues.
* Good knowledge of quality management systems
* Experience: 2-4 years experience working in a Healthcare manufacturing environment, with experience in qualification of small scale equipment (including the related software)
We offer you an attractive salary package and a contract with Randstad Professional.
Your benefits as a consultant:
* Gross salary dependent on your personal situation
* Additional net allowance of €80 per month, on top of your net salary
* The possibility to opt for a company car (under conditions) with a fuel card (also for private use) or a mileage allowance
* Meal vouchers
* Ecocheques of €250 per year
* Holiday pay and a 13th month
* 12 extra days off per year
* Hospitalization insurance with DKV
* Pension savings
* In addition, we also offer numerous training courses, fun activities, opportunities for growth, etc., to guide you throughout your career.