Hawkins Point Partners

Computer System Validation CSV Technical Leader

Lexington, MA, us

Company: Hawkins Point Partners

Category: IT / Computing / Software

Published on 2021-10-21 19:18:56

Job Description Hawkins Point Partners has an immediate need on its (remote work) Massachusetts team for a Computer System Validation (CSV) team leader with 21 CFR Part 11 expertise. This person will be responsible for a mission critical computerized system implementation, support system maintenance, and facilitate the retirement of legacy computer systems. This role will review and approve computerized system lifecycle documentation as well as provide Part 11/ Annex 11, and data integrity expertise to key stakeholders. Core Skills: Must understand the process to build data flows for computer validation, establish data chain of custody, have experience supporting drug manufacturing laboratory environments, and the ability to provide strategic guidance from a quality perspective. Must have experience supporting quality and data Integrity oversight, have SDLC process management and be able to support software quality assurance. Experience with Agile project management methodology along with strong customer service skills are important. Experience supporting Biopharma start up technology systems is a plus. The ideal candidate will work with non technical, business operational teams along with technical GXP Quality Assurance groups. Additional skills include, GAMP 5 and laboratory experience, Microsoft Office software. Day to day duties: Support business team operational functions and GxP Quality Assurance groups to provide supervision. Ensure regulatory compliance pertaining to system implementation and use of computerized systems in GxP areas. Support software quality team members and relevant internal stakeholders. Provide system analysis to identify and define high risk areas concerning patient safety, product quality and data integrity. Identify and escalate areas of risk or non-compliance to manager / leadership team. Execute periodic reviews and documentation of company computerized systems. Ability to execute in a GAMP 5 and laboratory experience, Microsoft Office software. At Hawkins Point Partners we believe in creating great experiences for our colleagues. We offer competitive compensation along with comprehensive benefit options to meet the diverse needs of our colleagues in their personal and professional lives. Company Description We help our clients realize business solutions through the effective use and implementation of technology. Our services include technical services in the areas of 21 CFR regulatory, Program/Project Management, Business Analysis, Quality Assurance, Oracle ERP support and Application Development. Our Consulting Services include Outsourcing Reset, Application Rationalization, Information Management, Mobile Solutions, and Enterprise Architecture and Integration. Please see our web site at www.hawkinspointpartners.com
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