Katalyst CRO
Join to apply for the
Computer System Validation Lead
role at
Katalyst CRO Continue with Google Continue with Google 8 months ago Be among the first 25 applicants Join to apply for the
Computer System Validation Lead
role at
Katalyst CRO 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
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 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. Seniority level
Seniority level Entry level Employment type
Employment type Contract Job function
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Computer System Validation Lead
role at
Katalyst CRO Continue with Google Continue with Google 8 months ago Be among the first 25 applicants Join to apply for the
Computer System Validation Lead
role at
Katalyst CRO 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
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 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. Seniority level
Seniority level Entry level Employment type
Employment type Contract Job function
Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Computer Specialist jobs in
Foster City, CA . San Francisco, CA $160,000 - $180,000 2 days ago San Francisco, CA $112,000 - $160,000 1 month ago San Francisco, CA $90,000 - $250,000 1 year ago San Francisco, CA $105,600 - $198,000 4 days ago Software Engineer, AI Platform - New Grad
San Francisco, CA $176,000.00 - $250,000.00 3 days ago San Francisco, CA $178,000.00 - $195,800.00 8 months ago San Francisco, CA $40,000.00 - $70,000.00 2 weeks ago San Francisco, CA $145,000.00 - $230,000.00 2 weeks ago Software Engineer - Data Acquisition / Web Crawling
Introduce Yourself - Submit your resume to Descope
San Francisco, CA $130,000.00 - $140,000.00 2 weeks ago San Francisco, CA $130,000.00 - $238,000.00 2 weeks ago San Francisco, CA $150,000 - $180,000 1 day ago Software Engineer, Frontend (All Levels)
San Francisco, CA $150,000 - $220,000 2 weeks ago San Mateo, CA $130,000 - $300,000 1 week ago Full Stack Software Engineer - Post-training
San Francisco, CA $150,000 - $230,000 4 months ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr