Job Description

The Senior Computer Systems Validation Specialist role is responsible for oversight of the computerized system lifecycle with focus on clinical and regulatory computerized systems. This role is highly cross-functional, and works closely with QA, business, and vendors to ensure compliance with internal Computer System Validation (CSV)procedures, FDA regulations, ICH-GCP guidelines, 21CFRPart11, and data integrity principles. Specific Responsibilities:

• Oversee the execution of qualification/validation activities of new software implementations and maintenance of existing systems.

• Author, review and and approval, of computer system validation documents, including validation plans, risk assessment and test scripts for the computer system implementation.
• Accountable for initiation/preparation and closeout of all CSV related change management documents.
• Implement appropriate validation methodologies as per company procedures in collaboration with IT, QA, Business, and system vendors.
• Work with project manager to develop timelines for validation in implementation timelines.
• Review and analyze the system requirements using risk-based approach.
• Evaluate proposed changes to validated computer systems and recommend level of validation activities required
• Support the identification and qualification of all computer systems which impact GxP operations using a risk-based methodology
• Author and/or review validation documentation e.g., System Risk Assessment, Validation Plan, System Requirements, Test Plan, test scripts/checklists, traceability matrix, deviation log, validation summary reports, and system use documentation (system admin, user admin procedures).
• Author and/or review decommissioning documentation of GxP software systems and any associated data migration activities.
• Work closely with IT, business, and QA owners to ensure appropriate validation of GxP computer systems.
• Duties may include internal compliance or efficiency improvement efforts within CSV department.
• Ensure that SOP\xe2\x80\x99s and procedural methodologies employed to maintain the validated state are reviewed and updated as needed.
• Provides active role in the continuous improvements of CSV processes and methodologies as per current regulations.

Requirements EDUCATIONAL/TECHNICAL REQUIREMENTS Key skills include minimum of a BS/BA in science-related or IT field, excellent writing skills, attention to detail, excellent interpersonal and organizational skills, and the ability to communicate effectively at several levels of an organization.

• Minimum of a BS/BA in a science-related or IT field
• 5 years validation, GxP, and Part 11 experience
• 5 years of CRO or pharmaceutical
• Experience with Veeva system is a plus

PERSONAL ATTRIBUTES

• Ability to work both independently and cross-functionally with IT, QA, and Business Areas to meet performance requirements in a dynamic fast-paced growth environment.
• Ability to work with vendors to manage
• Strong understanding of the organization\xe2\x80\x99s goals and objectives.
• Exceptional written and oral communication skills.
• Exceptional interpersonal skills, with a focus on listening and questioning skills.
• Strong documentation skills.
• Ability to present ideas in user-friendly language to non-technical staff and end users.
• Keen attention to detail.
• Proven analytical and problem-solving abilities.
• Ability to effectively prioritize and execute tasks in a high-pressure environment.
• Experience working in a team-oriented, collaborative environment.