Computer System Validation Lead

Computer System Validation Lead

Duration: Contract

Location: Foster City, CA (3 days Remote 2 Days to Foster City CA Office)

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 Client’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 and become proficient the EDMS (Electronic Data Management System), for
document review and 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

Required Experience / Skills:
Minimum of 10-12 years of experience working in CSV field and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.
Advanced knowledge and expertise Computer System Validation, FDA& international requirements and Part 11requirements.
Ability to master technical content through interaction with subject matter experts.
Effective communication and interpersonal skills.
Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.
Understanding of programming and relational database concepts is required.
Required Education:
BA/BS degree, e.g. biology, chemistry, computer science and/or technology disciplines is preferred.