QA Systems Associate (0.5 FTE)

at  Merus

DESCRIPTION

The Quality Systems department is responsible for the development, maintenance, and evolution of the Quality Management System of Merus to ensure compliance with international regulations and support the achievement of quality objectives. As Quality Systems Associate you act as Business Administrator of Merus eQuality Management System.

YOUR PROFILE

We are looking for a highly organized and detail-oriented individual with experience with Document Management Systems. The ideal candidate will have a background in document control and quality management processes. It is a big plus if you have had any experience participating in audits and inspections. Effective communication skills, ability to collaborate and a proactive approach to continuous improvement are essential.

Requirements:

• Degree in Biosciences or related field
• Minimum of 2-3 years relevant GMP work experience within biotechnology/ pharmaceutical /medical device industry, in a manufacturing or quality environment.
• Experience with MS Office (Word, Excel in particular)
• Proficient in an eDMS/LMS system, experience as business administrator is a plus.
• Knowledge of GMP; working knowledge of GCP, GDP
• Fluency in English (written and verbal)

In this position, you will be responsible for overseeing, supporting, and coordinating various aspects of the Quality Management System. Your key responsibilities will include:

• Act as Business Administrator and coordinate all aspects of the full operation of Merus eQMS including:
• Document Management
• Learning Management System (including study specific training)
• QMS (Change Control, Deviation handling, CAPA, Complaints, Supplier Management, Audit & Inspection)
• Manage GxP documents and ensure training is assigned appropriately
• Foster a quality mindset around Good Documentation Practices
• Collaborate with all GxP departments to provide customer service, analyze system incidents, and introduce system optimization
• Contribute to continuous development of Merus’ Quality Management System to address changing needs of Merus
• Compile, monitor and trend Merus quality indicators for weekly, monthly, and quarterly Quality Reviews
• Participate in and prepare for (internal) audits and inspections as SME.

In addition, you will support in several other areas, such as inspection activities, contractor qualification audits and assessing changes/new developments in GXP regulatory in order to roll them out internally.