Under the direction of a Validation Risk Partner, ensure the technical integrity of a product or system from a compliance perspective.
For regulated and/or non-regulated systems, as the SDLC subject matter expert, author plan and summary SDLC deliverables (e.g., Quality Assurance Plan or Change Plan, Development and Test Plan, Acceptance Test Plan, and Development Summary Report, Acceptance Test Summary Report, and Quality Assurance Summary Report or Change Summary).
Review SDLC deliverables upon request to ensure adherence to SDLC, policies and procedures, and system specific planning documents.
Coordinate the required assessments for new systems (e.g., Risk Profile, Security, Privacy, Supplier, etc.)
Partner with assigned Business Unit, Technical Unit including internal and external developers, Quality Unit, and testing representatives on project teams ensuring strategic approach is followed.
Build and maintain a positive, collaborative relationship across all disciplines
Understand and apply a risk based approach to validation activities and testing
Assist Project manager in developing project schedule as it relates to required SDLC activities
Provide SDLC and regulatory guidance to other level Validation Risk Specialists
Provide guidance on corporate policies, procedures and assessments.
A minimum Bachelor's degree in a science or technology discipline
8+ years of industry experience including computer system validation, SDLC, Validation, and/or QA experience.
Experience working in a Pharmaceutical environment in a regulated (GxP) environment
High level of expertise in computer system validation regulations including 21 CFR Part 11, Part 58, Part 210, Part 211 and Part 820 is required. Knowledge of the EU Annex 11 regulations is preferred.
High level of expertise in SDLC methodology (e.g., waterfall, agile, spiral) including change management
Excellent written and communication skills including thorough knowledge of Good Documentation Practices
High level of experience in managing and conducting change control, validation planning and summarization
High level of experience writing Quality Assurance or Validation Plans and Summaries as well as change plans and change summaries
High level of experience providing guidance for adherence to SDLC and corporate and regulatory procedures.
High level of experience in ITIL change management and SOPs supporting this process
Previous experience with Remedy or comparable tool for asset and change management
Experience with software such as document management and automated testing tools (e.g., First Docs (Documentum), HP Quality Center/Application Lifecycle Management).
Ability to prioritize and manage multiple projects / efforts concurrently.
Excellent interpersonal skills including ability to work as a team member in a collaborative environment
with minimal supervision.
High attention to detail.
Specialist needs intimate knowledge of end-to-end validation process and strong familiarity with SDLC deliverables. Preferred experience with validation of: