USDM validation analysts will support clients on a variety of compliance initiatives. We currently have an opportunity for a CSV Analyst who has about 5 yrs. of experience providing Periodic Reviews of Validated Computer systems, experience with validation of IT Application systems such as QMS, LMS, EDMS (Veeva or similar) and lab. Systems such as Empower/Nugenesis, LabX as well as computerized lab instruments such as HPLC/GC, UPLC, UV/VIS, TOC Analyzer, Malvern Rheometer, Beckman particle counter etc. The person should be well versed with respect to Part 11/Annex 11 compliance, data integrity and CSV, with good writing and speaking skills in professional life science (pharma/biotech) organizations.
• The validation analyst will provide an advisory role as needed. This may include:
o Advising clients on assigning proper risk to computer systems
o Advising clients on how to meet compliance requirements.
o Advising clients on developing test that provide adequate compliance coverage as well as thoroughly tests business requirements.
• Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA compliance requirements.
• Work with client business functions and subject matter experts to develop User Requirements, Functional, and Design Specifications to establish hardware/software requirements
• Develop test / validation scripts based on software / hardware design / configuration
• Develop Installation tests / qualifications scripts based on Design
• Develop Operation tests / qualifications scripts based on functional requirements
• Develop Performance tests / qualification scripts based on configuration
• Interact in a team environment, managing tasks and escalating issues as needed.
Education & Experience/Technical Competencies:
• University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.
• Minimum 3 to 5 years in pharmaceutical industry, focusing on Systems Validation.
• Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Expertise in use and validation of GMP systems.
• Fluent knowledge of rules and regulations: GAMP 5, CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
• Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)
• Ability to work independently.
• Strong organizational/ facilitation/communication skills.
• Strong verbal, written and presentation skills.