Validation Lead
Commercial Products
Posted on 4/30/2021
INACTIVE
Cloud computing services for pharmaceutical companies.
Company Overview
Veep's mission is to help R&D, quality, and regulatory teams eliminate inefficiencies and bring high-quality, safe, sustainable products to market without compromising quality. The company builds cloud-based tools for pharmaceutical research.
Locations
Columbus, OH, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
- Bachelor's degree in Engineering/Sciences or equivalent relevant technical experience
- At least 5+ years of experience in CSV role
- Hands-on experience with the validation of commercial enterprise applications (e.g., SFDC, SAP) used in the conduct of commercial regulated activities (Good Distribution Practice)
- Good understanding of the commercial industry regulations (e.g., PDMA, OIG, Sunshine Act, 21CFR203)
- Knowledge of Agile software development, and software testing methodologies
- Excellent written and oral communication skills, good decision-making skills, and time management skills
Responsibilities
- Lead and execute (as needed) the validation activities for Veeva's general releases, hotfixes, as well as product periodic revalidation
- Responsible for tracking, monitoring, and controlling the validation process
- To ensure timely delivery to meet pre-scheduled release dates and budgets
- Provide technical expertise, regulatory interpretation, and direction in regard to computer validation, federal regulations, and other quality system requirements
- Closely collaborate with Product Team to ensure requirements/specifications are defined in a clear, testable, and compliant format
- Effectively work with cross-functional teams (Product Management, SQA, Technical Operations) to ensure the validated state of the system is maintained
- Ensure requirements are adequately tested following a risk-based approach
- Identify and log issues found during validation execution. Work closely with Product and SQA teams to identify and prioritize issues early on and track validation incidents to closure
- Ensure clear traceability against all testing performed
- Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices
- Independent pre and post-execution review of validation test scripts
- Coordinates with cross-functional teams to design and execute test protocols
- Supports change control as validation technical resource and ensures timely completion of required tasks
- Perform validation impact analysis and risk assessments in conjunction with product teams
- Execute other projects/duties as assigned to ensure compliance across Veeva's product line and internal business systems
Desired Qualifications
- Experience with cloud-based applications and/or infrastructure compliance
- Understanding of Agile development methodology
- Working knowledge of GAMP 5
- Broader awareness or direct experience with “promotional materials” requirements (e.g., OPDP, APLB)