Validation Lead (CSV)

Job Title: Computer System Validation(CSV) Lead

Duration: Contract

Location: Foster City, CA (Remote)

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.

Please connect Mujeeb Khan at

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