| 100% Remote Work --- Computer System Validation Lead --- Long term contract at Remote, Remote, USA |
| Email: [email protected] |
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https://jobs.nvoids.com/job_details.jsp?id=1851606&uid= From: Mohit Jaiswal, Intelligenz IT [email protected] Reply to: [email protected] Hi, I hope you and your family are doing well. I have a good position for you with my client. This point of time I don't know whether you are looking for a new job or not. But just thought if I can share the details and then confirm from you about your interest level for the opportunity. If you are interested and an available consultant, send me your most updated resumes in word format and contact details. Job Title: Computer System Validation Lead Location: 100% Remote Work Duration: Long term contract 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 Gileads 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. Regards, Mohit Jaiswal Intelligenz IT Work : 646-502-7441 Keywords: business analyst information technology Alabama 100% Remote Work --- Computer System Validation Lead --- Long term contract [email protected] https://jobs.nvoids.com/job_details.jsp?id=1851606&uid= |
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| 08:36 PM 17-Oct-24 |