eQMS Specialist - Remote (Ref11132D)

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, India, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

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

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 account profile management, permission management and password resets.
• Mailbox management and query support.
• Process development.
• Client account set up/set down.
• Document Management:
• Assisting in the implementation and maintenance of programs and processes in relation to internal and client document management.
• Working with the Document Control & eQMS Manager to ensure that document control requirements are met throughout the duration of the document lifecycle. Ensuring appropriate maintenance and obsoletion.
• Coordination of Training:
• Creation, maintenance and obsoletion of job functions, curriculums and training requirements.
• Creation and maintenance of training records.
• Training creation across all system training types.
• Maintenance of training records including assigning new training, re-training and cancellation of training.
• Processing of System Reports:
• Running training reports for compliance monitoring and client/audit request purposes.
• Building reports and dashboards on request.
• Running regular document management reports.
• Other duties as assigned.
• General:
• Having a solid working knowledge of, and to comply with, the Standard Operating Procedures of ProPharma Group.
• Working in a professional manner at all times with clients, customers, team members and management.
• Complying with ProPharma Group's Health and Safety Policies.
• Ensuring the Confidentiality Statement within the Contract of Employment is adhered to at all times in respect of the data and property of ProPharma Group, its clients and employees of the business.
• Ensuring that any confidential information or personal data related to ProPharma Group and its clients is managed in accordance with Data Privacy regulations as described in ProPharma Group SOPs.
  

Qualifications

• Previous experience of working with an eQMS, Learning Management System or Document Management System preferred.
• Able to work within a team in a professional manner.
• Able to work independently on personal workload.
• Sound written and oral communication skills.
• Good accuracy and attention to detail skills.
• Good 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).
  

Additional Information

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.