- Responsible for Quality Risk Management Administrator include:
- Help to set up and maintain Quality Risk Management SharePoint sites (Quality Risk Register and Quality Risk Assessment).
- Ensure consistent style and format for all Quality Risk Register and Risk Assessment documents (forms and periodic updates) in accordance with documentation and existing processes, and work instructions.
- Process all risk assessment procedures.
- Assist in the mapping and remediation with all Shire procedures mentioning risk.
- Identify and participate in documentation revisions of Quality Risk Register Forms, Risk Assessment Reports, QRM procedures and work instructions.
- Communicate deliverables for each Quality Risk Register and Risk Assessments action including follow-up and active communication on issues and potential roadblocks to appropriate parties (Risk Owners, Risk Owners Department Heads, Risk Champions, and other members referenced in the appropriate QRM documents).
- Maintain a list of Quality Risk Register actions as well as active and completed Quality Risk Assessments per QRM procedures and work instructions.
- Maintain the Quality Risk Register and Quality Risk Management SharePoint and Iris website.
- Participate in Quality Risk Register and Risk Assessment review, meetings and QRM work stream teams and communicate/manage input and feedback from team members.
- Manage the COP schedule.
- Support coordination of Quality Risk Management activities related to risk assessments and trainings.
Education and Experience Requirements
- Bachelor’s Degree (or an equivalent combination of education and relevant experience).
- 5+ years relevant experience within a Quality Systems department in a cGMP environment. Knowledge of QRM principles would be extremely beneficial.
Key Skills, Abilities, and Competencies
- Strong written and verbal communication skills
- Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization
- Must be very proficient with Microsoft Office applications, specifically Word and Excel.
- Basic understanding of SharePoint application.
- Ensure that the original information required within the various templates (QRR Form and other QRM applications) adhered to the requirements specified within the appropriate QRM documents.
- The ability to formulate thoughts (meeting action requests) and outstanding actions into periodic management updates and reports.
- Complexity and Problem Solving
- Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level.
- Support continuous improvement efforts to ensure QRM documentation is efficient and compliant
- Identify and analyze opportunities for process improvement. Verify that documents (Quality Risk Register forms) contain accurate details and instructions corresponding with the activity
- Ensure that the information contained in documents correspond with the information of related documentation.
Ricky Bansal
Clinical Recruiter
732-429-1925
