Computer System Validation Consultant
5 days ago
**Responsibilities**:
- Create and refine validation protocols for GxP critical reports, focusing on Computerized Equipment Validation within the QC lab.
- Configure static Master Data for validated/GMP-compliant LabWare LIMS (version 6), specifically emphasizing Computerized Equipment.
- Actively participate in executing, reviewing, and approving validation protocols for Computerized Equipment.
- Generate Change requests and IT tickets tailored for report validation of Computerized Equipment.
- Validate business intelligence reports, showcasing expertise in necessary tests for qualification.
- Review and draft SOPs, specifically for Computer System Validation Projects, with a focus on Computerized Equipment.
- Develop documentation for Computer System Validation projects, including URS, FRS, FRA, HLCCD, etc.
- Address and resolve issues during Computerized Equipment validation, including deviations and change controls.
- Ensure compliance of computerized systems, especially LabWare LIMS and other Computerized Equipment, with relevant regulations.
- Draft templates for High-Level Risk Assessments, User Requirements Specification, Validation Plans, and Validation Summary Reports, emphasizing Computerized Equipment Validation.
- Act as a liaison between Quality Assurance and the project team, ensuring strict compliance with regulations for GxP software and Computerized Equipment.
- Manage planning and execution of Computerized Equipment Validation projects within established timelines and budgets.
- Coordinate effectively with teams, clients, and stakeholders, specifically for Computerized Equipment Validation.
- Oversee day-to-day operations of Computerized Equipment Validation projects.
- Ensure completeness, review, approval, and proper storage of project documents related to Computerized Equipment Validation.
- Keep the Computerized Equipment Validation team well-informed of project changes. Experience with Kneat and validation of around 15 computerized systems (LCE), excluding Electrical Equipment (EE).
**Required Qualifications**:
- Bachelor’s degree in business/technical field or equivalent education/experience.
- 3 to 5 years of experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment, involving IOQ/PQ authoring and execution, traceability matrices, and risk assessments.
- Prior experience with Takeda and familiarity with Emerson Delta V software is a plus.
- Strong technical skills in configuring various Laboratory systems, including Standalone instruments like Mass Spec, IC, Matersizer, UV, FTIR, DSC, etc.
- Understanding and ability to configure TCP/IP network connectivity between systems.
- Excellent knowledge of Desktop Operating systems, including Windows 2000, Windows 7, and Windows 10, covering permissions, user configuration, and peripheral device connections.
- Proficient in drive mapping, logon scripts, and analyzing system logs.
- Good understanding of Active Directory, Domain permissions, and LDAP.
- Advanced understanding of data system security for safeguarding electronic assets, intellectual property, and privacy.
- Experience in developing and implementing complex data exchange processes between information systems.
- Proficient in creating/developing moderately to complex functional requirements mapping to an Information System based on user needs.
- Ability to independently identify compliance risks and escalate when necessary.
- Self-starter with strong team communication skills.
- Proven ability to lead a team.
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