Computer Systems Validation Consultant
Apex Systems is seeking a Computer Systems Validation Consultant to join our team! We are actively interviewing and aiming to have the individual start by Sept. 3rd.
For immediate consideration, please send resumes to Kim Tran at firstname.lastname@example.org
- Create and manage validation lifecycle documentation including validation plans, user and functional requirements, technical and functional business process flows, risk assessments, IQ/OQ/PQ Test Scripts, traceability matrices, validation summary reports.
- Provide technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, and other applicable regulations or procedures.
- Create, review, and modify SOPs as appropriate.
- Work with project teams to select methods and techniques for obtaining desirable solutions for each project and work with QA to ensure compliance with regulations.
- Conduct/ assist in computer systems compliance assessments.
- Work collaboratively to ensure the development of CSV best practices.
- Bachelor’s Degree or higher is required
- 3 or more years’ related CSV experience
- Significant experience with GAMP 5, FDA Regulations US FDA (21 CFR Part 11, 210, 211, 820) and EU EMEA regulations.
- Experience with SDLC - System Development Life-cycle in a GxP environment
- Excellent communication and interpersonal skills.
- Ability to manage conflict and influence others
- Work well both independently and as a member of a high performance team.
- Proven ability to effectively collaborate with others, interpreting needs and requirements at the business process and technical level