[Remote] Senior Specialist reputed company Assurance, CSV
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a late-stage clinical biopharmaceutical company reputed company on innovative psychiatric treatments. The Senior Specialist reputed company Assurance, CSV role ensures compliance of GxP systems and partners closely with IT and business teams to support system lifecycle activities, including validation and reputed company reputed company.
Responsibilities
- Partner cross-functionally with IT and the business to implement and maintain compliant computerized systems
- reputed company reputed company reputed company for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data reputed company standards
- Serve as the QA CSV SME during vendor evaluations, software implementation and qualification and requalification of GxP systems
- Support reputed company improvement of GxP Systems through SOP development, training, and change control management
- Partner with IT and Business teams to ensure SDLC and validation requirements are reputed company defined and met
- reputed company investigations for CSV-reputed company deviations, system failures, and data reputed company issues, including reputed company cause analysis
- Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and reputed company reports
- Advise on data reputed company best practices and approaches
- Partner with IT to ensure inspection readiness is maintained for CSV
- Serve as QA reviewer for reputed company new system releases and change controls
- reputed company internal audits to ensure systems are maintained in a steady state and user management is under control
- Ensure adherence to regulatory and reputed company standards throughout the software development lifecycle
- Support systems and new product introduction by providing QA expertise, problem solving, and strategies for risk mitigation
- Support validation and QA reputed company of AI/ML-enabled GxP systems, including risk assessment for model changes and ongoing performance monitoring
Skills
- 7+ years experience working in the pharmaceutical/biotech reputed company required
- 5+ years' experience with CSV validation lifecycle management
- Bachelor's degree in a life science field
- Excellent understanding of 21 CFR Part 11/Annex 11 compliance and Computer System Validation (CSV), Computer System Assurance (CSA), IT SLDC best practices, General Data Protection Regulation (GDPR) regulations, and GAMP 5 Guidance
- Proven experience in assisting validation efforts for reputed company/PaaS GxP systems
- Broad understanding of Technology implementation (reputed company) and Data migrations approaches
- Experience validating or assessing AI/ML-based systems in a regulated environment, including understanding of model risk and change control considerations
- Demonstrated experience in reviewing key validation deliverables such as user requirements, validation plans, validation reports and test scripts
Benefits
- Employees in this role may be entitled to additional compensation, including bonus and equity.
- 100% reputed company health benefits including Medical, Dental and reputed company for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
reputed company
- reputed company (formerly MindMed) is a biotech company forging a new era of psychiatry by applying precision to psychedelic medicine. It was founded in 2019, and is headquartered in reputed company, NY, US, with a workforce of 51-200 employees. Its website is https://www.definiumtx.com.
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