Computer System Validation Lead CSV Lead
Computer System Validation Lead CSV Lead
Posted on :
20-10-2024
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Job Description
Computer System Validation Lead / CSV Lead
REMOTE / Work From Home
** rate : Market / Flexible
REMOTE / Work From Home
** rate : Market / Flexible
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 CSVrelated 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 become proficient the EDMS (Electronic Data Management System) for document review 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
Experience / Skills:
- Minimum of 10 years of experience working in CSV field and GMP Pharmaceutical / Biotechnology / Medical Device environment
- Advanced knowledge and expertise Computer System Validation FDA international requirements and Part 11 requirements
- Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required
- Ability to master technical content through interaction with subject matter experts
- Laboratory experience as a chemist or microbiologist et al is preferred
- Understanding of programming and relational database concepts is required
- BA/BS degree; e.g. Biology Chemistry Computer Science and/or Technology disciplines is preferred
Thanks & Regards
Mateenuddin
*************
*************
Employment Type
Full Time
Key Skills
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