Senior Computer System Validation Consultant Job at Avispa Technology, San Diego, CA

c1hMNDZxZFFlSjFqUisvWlVrbmU0UnY5cWc9PQ==
  • Avispa Technology
  • San Diego, CA

Job Description

Summary: Reports
  • Perform requalification of existing computer systems and support Periodic System Reviews to maintain a validated state.
  • Oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release, update, or iteration.
  • Act as the Quality Lead for project teams, guiding the implementation of validation, security, and project management deliverables at appropriate stages of the system lifecycle.
  • Provide expert guidance to project teams on compliance and security control requirements to ensure data integrity and system reliability are integrated by design.
  • Review and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory expectations.
  • Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA), and support the execution of corrective action plans.
  • Support evaluation of existing legacy systems for technical integration and tool management.
  • Advise on the implementation of compliance and security controls for both new and existing systems.

Senior Computer System Validation Consultant Qualifications:

  • 8+ years of experience in the Life Sciences industry (Consulting or Industry) with a focus on Computer System Validation and Quality Compliance.
  • Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (an equivalent combination of education and experience may be considered).
  • Expert understanding of: FDA 21 CFR Part 11, 210/211, and 820, EU EudraLex Volume 4 (Annex 11 and Chapter 4), GAMP 5 and risk-based validation approaches, ALCOA+ principles and data integrity frameworks
  • Strong IT/technical background with the ability to understand the complexities of networked programs and infrastructure.
  • Familiarity with laboratory, manufacturing, and quality management systems for GMP operations, including: Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES)
  • Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
  • Experience developing training materials and delivering training to employees on CSV topics.
  • Ability to lift up to 20 pounds as needed.

Shift:

  • Standard hours 8am to 5pm - some flexibility to work earlier/late as needed.

#PP

Job Tags

Full time, Contract work, Temporary work, Local area, Shift work

Similar Jobs

Stetson Convention Services, Inc.

Graphic Designer Job at Stetson Convention Services, Inc.

 ...National Convention and Tradeshow Contractor located in Pittsburgh, PA is seeking a full-time or part-time entry level Graphic Designer/ Concept Developer of Trade Show Displays. This position comes with the opportunity for advancement. Our ideal candidate will possess... 

Madison Allied LLC

New York Real Estate Agent- Live Leads Provided Job at Madison Allied LLC

 ...Job description Licensed Real Estate Agents Join the Remote Team at Madison Allied (New York)...  ...Work from anywhere with no required office time or set hours. Competitive Commission...  ...opportunity with flexible scheduling part-time or full-time. If you're ready to grow... 

Valbin XCTC

Chinese Interpreter/Translator Job at Valbin XCTC

 ...sector and business entities. We currently support a government customer which requires translations, as well as interpretations, from Chinese to English and vice versa, on an as needed basis. Job Summary: We are seeking professional Chinese Linguists that can provide... 

LP Consulting

Luxury Travel Planner Job at LP Consulting

 ...Join Our Team as a Luxury Travel Planner! Do you have a passion for travel and a knack for planning unforgettable experiences? As a Luxury Travel Planner , youll help clients bring their dream vacations to life. From tropical escapes to cultural journeys, youll... 

Sage

Customer Success Specialist Job at Sage

 ...Job Description The Sage Customer Success teams sole mission is to ensure the success of our customers. The Sage 50 Customer Success Specialist (CSS) is responsible for providing technical leadership, innovations, and capabilities to the Sage 50 customer base with...