eQMS Specialist

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job Summary

The eQMS Specialist provides comprehensive administrative support for the Electronic Quality Management System (eQMS) in an accurate and efficient manner.

Essential Functions

Supervision, mentoring and advice will be provided to support the eQMS Specialist in the conduct of the responsibilities listed below:

System Administration:

• System administration tasks including personnel changes, permission changes and password resets.
• Query support, mailbox management, process development.

Document Management:

• Assist in the implementation and maintenance of programs and processes in relation to document management.
• Working with the Document Control and eQMS Manager to ensure that document control requirements are met throughout the duration of a document's Lifecyle. Ensuring appropriate filing, archival and obsoletion.
• Supporting with the delivery of training on Document Management and Control processes and the use of the Document Management System.

Coordination of Training:

• Assigning new training, re-training, and cancellation of training.
• Classroom creation and training scheduling.
• Creation and maintenance of training requirements, curriculums, and job functions.
• Setting up/down of clients in the system.
• Maintenance of training records.

Processing of System Reports:

• Running training reports to monitor compliance and for client/audit requests.
• Building reports and dashboards on request.
• Running regular document management reports.

General:

• Having a solid working knowledge of, and to comply with, the Standard Operating Procedures of ProPharma.
• Working in a professional manner at all times with clients, customers, team members and management.
• Ensuring that any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations as described in ProPharma SOPs.
• Other duties as assigned.

Qualifications

• Able to work within a team in a professional manner.
• Sound written and oral communication skills.
• Good accuracy and attention to detail skills.
• Solid level of productivity on all tasks.
• Sound organizational and prioritizing skills showing an effective workload management system.
• Able to understand and follow processes.
• Pleasant and professional telephone manner.
• Computer literacy (MS Office).
• University/ Associate's degree and/or or appropriate relevant work experience.
• Previous experience working with an eQMS is essential
• Previous experience working in a contact center, Medical Information or Pharmacovigilance function.