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Contamination Control Specialist Freelance

Engineering
Amsterdam
English and Dutch, Dutch, French and Dutch, English and Swedish, German and English, Polish and English, English

Wanted! Contamination Control Specialist. Are you up for a challenge and available the upcoming 4 months? Are you an expert within sterility assurance and contamination control? Then I am looking for you! Please send me your resume!The Sterility Assurance Specialist (SAS) is tasked with ensuring the sterility of our products by designing, implementing and monitoring processes and control systems that prevent and control microbial contamination. This specialist works closely with both the production and quality departments to ensure compliance with regulations and industry standards.

Responsibilities include evaluating processes, systems and equipment within this field, establishing the contamination control strategy (CCS), providing advice to the organization regarding product sterility and contamination control, and assessing the impact of deviations that pose a potential hazard to product sterility. Leading multidisciplinary projects in this specialist area is also part of the tasks of this role.This is a temporary position for 4 months. The all-in hourly rate is max. €110,-

What will happen when you apply? Within four working days we will let you know whether you are qualify for the position. If you do we will schedule an interview (digital or live). In this interview, we will inform you about the vacancy, the company and the procedure. If we both agree this is a fitting opportunity we will introduce you to our client and continue to guide you through the whole application process. The Independent Recruiters Group has a large team of specialized recruitment consultants. Every recruiter has a strong focus regarding his/her own field of expertise. This makes them the ideal sparring partner for both you, as the candidate, and the client.

Requirements:

* Strong microbiological knowledge is essential for this role, as well as experience with implementation of EU requirements.
* Set up and lead the Contamination Control Board
* Support the microbial assurance aspects of the Quality System.
* Co-ordinate use of all microbial services.
* Support the review and development of procedures for all microbial assurance activities.
* Implement the GMP training program for clean room and other appropriate staff.
* Support the Quality team in the preparation for and performance of all audits and inspections as Subject Matter Expert for Contamination Control.
* Have a detailed knowledge of the legal and regulatory framework regarding Sterilization and Environmental monitoring.
* Proactive attitude and good teamplayer. Good influencing skills with the ability to coach and guide Prothya employees on processes in the field of contamination control.
* Excellent communication, preferably both Dutch and English
* Experience of conducting GMP audits, internal and relevant external audits.

About the company:

The Sterility Assurance Specialist (SAS) is tasked with ensuring the sterility of our products by designing, implementing and monitoring processes and control systems that prevent and control microbial contamination. This specialist works closely with both the production and quality departments to ensure compliance with regulations and industry standards