Quality & Regulatory System Specialist
Job TitleQuality & Regulatory System Specialist
The Quality & Regulatory System Specialist for CFM and TW CH is a vital organizational role in support of the CFM and TW CH applications. The role is responsible for understanding the CFM and TW CH applications and processes to work closely with the business users to enable their usage of the application to execute their business processes. Support of the applications includes activities such as consulting on issues with customers and IT, managing communication via email notices, newsletters and websites, and delivering the business owned software validation documents for projects and changes enhancing the applications.
- Author and gain approval for high quality application validation documents which are compliant with PHPR0210, Validation Planning Procedure, and associated documents. Monitor documents and update as needed. Execute validation activities, per assigned role, which results in our customers’ acceptance of the application.
- Review and provide input on technical specification validation documents to ensure the system design will meet our customer’s requirements and objectives.
- Coordinate and support the deployment of new functionality to current users.
- Draft, submit for approval and monitor change requests needed to support compliance to regulatory standards and to improve business processing.
- Develop, maintain and deliver software application training content which is instructive, easy to follow and value-added for our customers.
- Lead the application Key User Groups to provide a forum for communication on issues and status, best practice sharing, and change request identification and prioritization.
- Provide efficient and effective email and website communication to our customers concerning topics such as application status, changes and training.
- Report out on the performance of Q&R tool applications per the Application Health Reports.
- Utilize the IT ticket management system (SNOW or other) to enter, monitor and escalate, when necessary, application issues. Work with IT to ensure communication of issue status.
- Identify, develop and implement queries and reports which require administrative permissions or a high degree of system knowledge which cannot be transferred easily to our customer.
- Lead standard tool deployments (roll outs which do not require configuration changes to workflows or functionality) across Philips as needed.
- A minimum of two years’ experience acting as a subject matter expert in system support to include providing tool navigation and query/report development coaching.
- providing Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5
- Experience in executing validations of application systems
- Experience with business application implementation projects including being an active contributor on projects with deliverables per a project timeline
- Solid Analytical skills – demonstrated ability to trouble-shoot complex process/system issues
- Demonstrated ability to understand and develop processes and training material
- Experience and demonstrated ability providing training to adult learners in the use of software applications
- Results oriented and resourceful individual with solid leadership and interpersonal skills
- Demonstrated ability to interact and communicate (both oral and written) in Standard English, including demonstrable writing skills, speaking, and comprehension; ability to communicate across levels of the organization
- Strong Business Partnering skills
- Strong PC skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications
- Ability to create ad hoc reports as needed per requestor specifications and agreed upon dates
- BA/BS degree preferred
- Knowledge of the CFM Clarify and TrackWise complaint handling tools preferred
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance
In case of difficulties with your job application please send an email to [email protected]
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