Responsible for the implementation and optimization of the eQMS system across Group sites. Manages user access and rights, conducts user training, and provides daily support. Translates eQMS functions and workflows into documented procedures within the quality management system.
B. PRINCIPAL JOB DUTIES & RESPONSIBILITIES:
The incumbent will:
* Manage the lifecycle of the Quality Management Software as a Service, ensuring effective provisioning to global teams.
* Install/configure Dev/Test and Production environments and develop new workflows, including validation and documentation.
* Provide operational oversight globally and conduct user and local System Administrator training.
* Collaborate with the software provider in a project manager role for global rollouts, addressing system issues, proposing enhancements, and implementing additional functionality.
* Assist project teams and process owners in the initiation and planning phases of module implementation, offering technical support.
* Develop reports for end users and management, facilitating real-time reporting.
* Incorporate eQMS policies, procedures, and work instructions into the Quality management system and training documents.
* Contribute to and maintain system standards.
* Collaborate with IT and local sites for timely application version upgrades and configuration of new services.
* Define and manage user administration in coordination with Quality, Regulatory, and HR departments.
C. REQUIRED SKILLS, KNOWLEDGE, AND EXPERIENCE:
* Minimum of 5 years of professional experience in systems administration.
* Previous experience with Master Control in aMedtech, Medical Device,p
esponsible for the implementation and optimization of the eQMS system across Group sites. Manages user access and rights, conducts user training, and provides daily support. Translates eQMS functions and workflows into documented procedures within the quality management system.
B. PRINCIPAL JOB DUTIES & RESPONSIBILITIES:
The incumbent will:
* Manage the lifecycle of the Quality Management Software as a Service, ensuring effective provisioning to global teams.
* Install/configure Dev/Test and Production environments and develop new workflows, including validation and documentation.
* Provide operational oversight globally and conduct user and local System Administrator training.
* Collaborate with the software provider in a project manager role for global rollouts, addressing system issues, proposing enhancements, and implementing additional functionality.
* Assist project teams and process owners in the initiation and planning phases of module implementation, offering technical support.
* Develop reports for end users and management, facilitating real-time reporting.
* Incorporate eQMS policies, procedures, and work instructions into the Quality management system and training documents.
* Contribute to and maintain system standards.
* Collaborate with IT and local sites for timely application version upgrades and configuration of new services.
* Define and manage user administration in coordination with Quality, Regulatory, and HR departments.
C. REQUIRED SKILLS, KNOWLEDGE, AND EXPERIENCE:
* Minimum of 5 years of professional experience in systems administration.
* Previous experience with Master Control in a Medtech, Medical Device, Pharma, Biopharma/biotech, or healthcare setting preferred.
* Demonstrated proficiency in solution deployment and project management.
* Advanced or engineering-level computer skills in Microsoft Excel or similar software.
* Familiarity with HTML language preferred.
* Ability to perform major administrative tasks independently, with strong troubleshooting skills.
* Understanding of industry requirements and trends, particularly FDA Guidance for Industry on "Data Integrity and Compliance with cGMP."
* Familiarity with and previous experience working with Master Control, preferably in a System Administration capacity.
* Strong communication, presentation, and organizational skills.
* Ability to exercise good judgment within defined practices and policies.
* Detail-oriented with a strong work ethic and adherence to strict timelines for reporting and communication.
* Understanding of GDPR considered an advantage.
harma, biopharma/biotech, or healthcare setting preferred.
* Demonstrated proficiency in solution deployment and project management.
* Advanced or engineering-level computer skills in Microsoft Excel or similar software.
* Familiarity with HTML language preferred.
* Ability to perform major administrative tasks independently, with strong troubleshooting skills.
* Understanding of industry requirements and trends, particularly FDA Guidance for Industry on "Data Integrity and Compliance with cGMP."
* Familiarity with and previous experience working with Master Control, preferably in a System Administration capacity.
* Strong communication, presentation, and organizational skills.
* Ability to exercise good judgment within defined practices and policies.
* Detail-oriented with a strong work ethic and adherence to strict timelines for reporting and communication.
* Understanding of GDPR considered an advantage.
