CSV Analyst
4 weeks ago
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- Responsible for ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures and will drive improvements in line with regulatory changes (including but not limited to 21 CFR Part 11, EU GMP Annex 11 and Data Integrity Guidance).
- Provide technical oversight for computerised instrument validation (CSV) processes, in accordance with site and corporate procedures and GMP guidelines. The activities include, but are not limited to; the oversight for Validation Plans and Strategies, Risk Assessments, Requirement Specifications, Testing, Data Migration, SOPs, Change controls and Deviation Investigations.
- Manage, co-ordinate, develop and execute computer system validation deliverables for new and existing projects. This includes development and management of project plans, prioritizing validation activities in line with the overall project schedules.
- Liaise with vendors to design and deploy computerised instrument solutions to integrate with existing onsite IT services & infrastructure (backup, database, patching etc).
- Participate in and support audit activities.
- Participate, contribute and report at team meetings.
- Responsible for ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures and will drive improvements in line with regulatory changes (including but not limited to 21 CFR Part 11, EU GMP Annex 11 and Data Integrity Guidance).
- Provide technical oversight for computerised instrument validation (CSV) processes, in accordance with site and corporate procedures and GMP guidelines. The activities include, but are not limited to; the oversight for Validation Plans and Strategies, Risk Assessments, Requirement Specifications, Testing, Data Migration, SOPs, Change controls and Deviation Investigations.
- Manage, co-ordinate, develop and execute computer system validation deliverables for new and existing projects. This includes development and management of project plans, prioritizing validation activities in line with the overall project schedules.
- Liaise with vendors to design and deploy computerised instrument solutions to integrate with existing onsite IT services & infrastructure (backup, database, patching etc).
- Participate in and support audit activities.
- Participate, contribute and report at team meetings.
Key Requirements:
- Bachelor's Degree (Level 8) in Information Technology, Computer Science, Engineering or related field.
- Minimum of 3+ years of experience in a pharmaceutical or other regulated industry.
- Extensive knowledge and experience in development and execution of Computer system validations.
- Extensive understanding of regulatory requirements associated with CSV, including ER/ES(21CFR Part 11), security, and data integrity.
- Demonstrated initiative to build relationships, learn new business processes and identify opportunities.
- Influencing skills and the ability to work in cross-functional team environments, as well as independently.
- Analytical and problem-solving skills.
- Excellent communication skills.
- Experience in administration of computerised lab equipment.
- Experience of quality control laboratory IT systems (i.e. Empower, Lab Vantage, etc.).
- Seniority levelMid-Senior level
- Employment typeFull-time
- Job functionBusiness Development and Sales
- IndustriesIT Services and IT Consulting
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