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- Supports cGMP qualification and ISO 9001:2015 certification efforts.
- Assists in developing the computerized systems program.
- Collaborates with stakeholders to deploy and implement computerized systems, including LMS, EDMS, ERP, and software development.
- Maintains and improves computerized systems through procedure creation, review, and approval.
- Manages computerized system applications through validation, maintenance, quality administration, training, and process improvement.
- Executes documentation for CSA and CSV activities, including qualification and validation projects.
- Performs failure analysis, risk assessments, and problem-solving for system deficiencies and deviations.
- Conducts internal and external audits for system compliance with regulatory frameworks.
- Ensures compliance with relevant regulatory requirements such as GxP/GMP.
- Develops templates for risk assessments, user requirements, validation plans, and reports.
- Implements reporting tools for analysis, trending, and metrics.
- Assists in SOP, training material, and work instruction development.
- Acts as a liaison between QA and project teams to ensure regulatory compliance.
- Leads validation remediation strategy development for GxP systems.
- Manages, coaches, and trains project/internal resources as needed.
- Maintains inspection readiness and supports audit and inspection activities.
- Contributes to QMS initiatives as assigned.
- Provides QA approvals as needed.
- Takes on additional tasks and projects to meet business objectives.
- BA/BS with 7+ years of Pharma/Biotech Quality Management Systems (QMS).
- Experience with software, computerized systems, and/or control system validation.
- Experience with eQMS (EDMS, LMS, etc.). Experience with Veeva eQMS and CMMS is a strong plus.
CSV Engineer - Thousand Oaks, United States - Astrix Inc
Description
Fast-growing and innovative Biotechnology Company is seeking a CSV Engineer specialized in QMS to join their dynamic team This is a direct hire opportunity, allowing for hybrid work model. Must be able to go into the office at least twice per week
Responsibilities:
Requirements: