XTN-6A59772 | MASTERCONTROL CONSULTANT

We are seeking a skilled and experienced QMS (MasterControl) Consultant to join our team. The QMS (MasterControl) Consultant will be responsible for providing expertise in the implementation, configuration, and maintenance of QMS (MasterControl) software to support our internal business operations. The successful candidate will collaborate with internal stakeholders to identify requirements, design solutions, does unit and system integration testing, deliver training to end-users and support user acceptance testing. Close collaboration with business users from the GC International Headquarters and from all regions, the global team, PMO and the QMS (MasterControl) team in the USA is required for this role. The QMS (MasterControl) consultant will be reporting to the Digital Solutions Global QMS (MasterControl) Project Manager and CSV Compliance specialist.

• Health Insurance/HMO
• Enjoy unlimited MadMax Coffee
• Diverse learning & growth opportunities
• Accessible Cloud HR platform (Sprout)
• Above standard leaves

Main responsibilities:

• Collaborate with business stakeholders to gather requirements for QMS (MasterControl) system configuration.
• Configure and customize QMS (MasterControl) software to meet the specific needs of the organization.
• Develop and maintain system documentation, user guides and test scripts that are CSV compliant.
• Performs unit and system integration testing
• Provide end-user training and support for QMS (MasterControl) system.
• Support QMS (MasterControl) system user acceptance testing.
• Provide end-user account management, including, but not limited to the setup, unlocking, and disabling of users.
• Troubleshoot and resolve technical issues related to QMS (MasterControl) software.
• Stay current on industry best practices and new features of QMS (MasterControl) software.

Main Requirements:

• Bachelor’s degree in computer science, Information Technology, or related field.
• Proven experience having worked in the quality management department or as a QMS (MasterControl) Consultant or in a similar role.
• Knowledge of a QMS software and its modules like MasterControl.
• Experience with QMS procedures, processes and ISO quality certifications
• Willing to learn QMS system configuration, customization, and integration.
• Excellent communication, organizational and interpersonal skills
• Ability to work independently and as part of a team.
• Strong problem-solving skills and attention to detail.
• Service oriented, project-oriented, result-oriented and flexible
• International work experience in a continues changing environment is an advantage
• Experience to work in a multicultural cross functional environment
• Mainly working on a hybrid work setup, but willing to travel worldwide when needed
• Profound knowledge of and able to communicate in the English language
• Knowledge of Japanese is a plus but not required.
• Strong understanding of regulatory requirements and guidelines related to computer system validation, including FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP.
• Experience with validation of various types of computerized systems and regulatory compliance software.

We offer you:

• Challenging job in a growing international company
• Multicultural environment
• Full time employment with a contract for an indefinite period
• Flexible hours
• Competitive salary including benefits