Bio-Rad Labs Quality Manager and Document Administrator in Prague, Czech Republic

Job Description

Scope of the activity

Contractor performs organizational and administrative work associated with the management of Bio-Rad Czech Republic ISO 9001 Quality Management System in order to sustain and renew the ISO 9001 certification of Bio-Rad Czech Republic.

The Contractor represents the interest of Bio-Rad Czech Republic before the State Institute for Drug Control (SÚKL – Státni Ústav pro Kontrolu Léciv) regarding all registration and quality related activities (including notification of SUKL on Bio-Rad Field Actions) in Czech Republic

Working conditions

The Contractor performs the activities listed in the Scope of activity at the office of the Bio-Rad Czech Republic in order to be able to gather all relevant information that is required for the above mentioned activities.

The Contractor should carry out the defined activities at his best knowledge, maximum quality and in compliance with the instructions of the the Bio-Rad Czech Republic's Authorized Representative.

Bio-Rad Czech Republic provides appropriate working conditions for the Contractor to be able to perform his duties described in this contract.

Documents that are created under the activity of the Contractor are the exclusive property of Bio-Rad Czech Republic.

The Contractor is not authorized to share any Bio-Rad related confidential information or business facts with any third parties. “Bio-Rad related confidential information” includes the confidential information of Bio-Rad Czech Republic and its affiliates.

The Contractor shall not carry out any legal acts in the name of Bio-Rad Czech Republic.

Required Skills

Quality system management related educational background to be able to renew ISO 9001:2009 to ISO 9001:2015.

Contact with SUKL to be able to report Field Safety Quality Actions and report registration notifications.

Required Experience

Minimum 3 years experience in Quality Management systems (preferably ISO 9001)

Experience in contacting SUKL.

Tracking Code: 11388-446

Job Location: Prague, , Czech Republic

Department: Regulatory/Quality(3042)

Position Type: Full-Time/Regular

Division: (RAQA)QA