Quality and Regulatory Systems Specialist

The Q&R Specialist is a vital organizational role in support of the ValGenesis upgrade project and Non-Product System Software (NPSS). The role is responsible for supporting the NPSS system and processes and will be working closely with Q&R and IT to ensure a successful upgrade of the ValGenesis application. Support includes activities such as generating training materials, user guides, validation documentation, and participating in the day to day project activities.

The ValGenesis Q&R Specialist is critical to Philip's business to ensure that the ValGenesis upgrade project is staffed to fulfill the project activities, including generating validation documentation, training materials, user guides, procedures, and participation in project meetings.

Key Areas of Responsibilities:

• Author and/or review application validation documents, including user guides, which are compliant with NPSS procedures and associated documents. Monitor documents and update as needed. Execute validation activities, per assigned role, which results in our customers' acceptance of the application.
• Provide support in the design and development of the ValGenesis training materials for existing users and new users.
• Provide support in training the ValGenesis users.
• Support the application deployment to current users.

Profile:

• 3+ years of experience working in disciplined regulated industry in the application of automated technology, particularly 21 CFR Part 11 & Part 820, ISO 13485, GAMP 5
• BA/BS degree required
• Strong knowledge of software validation
• 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
• Results oriented and resourceful individual with good interpersonal skills
• Demonstrated ability to interact and communicate (both oral and written), including demonstrable writing skills, speaking, and comprehension
• Strong PC skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications

In this role, you have the opportunity to

Act as a Q&R Specialist in support of our ValGenesis application and Non-Product System Software (NPSS) processes. You will work closely with IT and Quality & Regulatory.

You are responsible for

• Author and/or review application validation documents, including user guides, which are compliant with NPSS procedures and associated documents. Monitor documents and update as needed. Execute validation activities, per assigned role, which results in our customers? acceptance of the application.
• Provide support in the design and development of the ValGenesis training materials for existing users and new users.
• Provide support in training the ValGenesis users.
• Support the application deployment to current users.

To succeed in this role, you should have the following skills and experience

• BA/BS degree required
• 3+ years of experience working in disciplined regulated industry in the application of automated technology, particularly 21 CFR Part 11 & Part 820, ISO 13485, GAMP 5
• Strong knowledge of software validation and 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
• Results oriented and resourceful individual with solid leadership and interpersonal skills
• Demonstrated ability to interact and communicate (both oral and written) in English, including demonstrable writing skills, speaking, and comprehension; ability to communicate across levels of the organization
• Ability to create ad hoc reports as needed per requestor specifications and agreed upon dates