What are the responsibilities and job description for the Computer System Validation Lead / CSV Lead position at TechnoGen?
Computer System Validation Lead / CSV Lead
REMOTE / Work From Home
rate : Market / Flexible
We are looking for a CSV Lead with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.
Responsibilities :
Improve the effectiveness and efficiency of the existing CSV delivery model through the creation of various templates, stools, training courses, and the periodic collection of KPI metrics
Provide thought leadership for GMP Systems by working across different departments to deliver CSV-related programs, innovations, and communications
Contribute to the operational and process improvement initiatives related to Quality and Compliance
Apply CSV expertise to make a major contribution to a specific business unit or department
Interpret and execute company policies and procedures that typically and recommend modifications to operating policies
Develop Validation testing strategy in accordance with Gilead's policy and procedures
Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites
Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projects
Learn, become proficient the EDMS (Electronic Data Management System), for document review, approval and ELMS (Electronic Leaning Management System) for documenting and performing assigned training
Prepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems :
Standard Operating Procedures (SOPs)
Work Instructions (WIs)
Forms
User Manuals / User Guides / User References / Quick Reference Guides and Training Material
Training Plans
Reference Documents
Specifications
Reports
Experience / Skills :
Minimum of 10 years of experience working in CSV field and GMP Pharmaceutical / Biotechnology / Medical Device environment
Advanced knowledge and expertise Computer System Validation, FDA, international requirements and Part 11 requirements
Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required
Ability to master technical content through interaction with subject matter experts
Laboratory experience as a chemist or microbiologist, et al is preferred
Understanding of programming and relational database concepts is required
BA / BS degree; e.g. Biology, Chemistry, Computer Science and / or Technology disciplines is preferred
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