Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)
Validation testing strategy in accordance with Gilead's policy and procedures
closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projects
with understanding the business requirements, analyze and help translate into functional requirements for assigned LIMS projects
closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS application
review & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projects
for Qualification protocols execution and final report view and approval for LIMS projects
"Data Integrity" related- risk assessments,
investigations suggest implementing remediations in CGMP operations.
Data Integrity compliance/impact assessments, risk assessments, and create short executive summary reports.
with the external partner or internal site to assess their DI maturity state and document the results of the assessment.
Required Experience / Skills:
of 6-10+ years of experience (Hiring for multiple roles Junior, Mid and Senior levels) working on a Labware LIMS application and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.
knowledge and expertise Computer System Validation, FDA& international requirements and Part 11requirements.
to master technical content through interaction with subject matter experts.
communication and interpersonal skills.
Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.
of programming and relational database concepts is required.
Required Education:
BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.