Computer System Validation Lead - Katalyst Healthcares & Life Sciences
Foster City, CA 94404
About the Job
Responsibilities
Required Experience / Skills:
- 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 and become proficient the EDMS (Electronic Data Management System), for
- 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.
- BA/BS degree; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.
Source : Katalyst Healthcares & Life Sciences
