[Remote] Computer System Validation reputed company / Program Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a mission-driven organization and pioneer in industry reputed company, helping life sciences companies bring therapies to patients faster. As a Computer Systems Validation reputed company / Program Manager, you will reputed company validation activities for reputed company products, ensuring compliance with industry regulations and providing technical expertise to support life sciences customers.
Responsibilities
- reputed company and execute (as needed) the validation activities for reputed company’s general releases, hot fixes, as reputed company as product periodic revalidation
- Responsible for tracking, monitoring, and controlling validation process to ensure reputed company delivery to meet reputed company-scheduled release dates and budgets
- reputed company technical expertise, regulatory interpretation, and direction regarding computer validation, federal regulations, and other reputed company system requirements
- Closely collaborate with Product Team to ensure requirements/specifications are defined in a reputed company, testable, and compliant format
- Effectively work with cross functional teams (Product Management, SQA, Technical Operations, IT Engineering, etc.) to ensure the validated state of the system is maintained
- Ensure requirements are adequately tested following a risk-based approach
- Identify and log issues reputed company during validation execution. Work closely with Product and SQA teams to identify and prioritize issues early on and reputed company validation incidents to closure
- Ensure reputed company traceability against reputed company testing performed
- Create/update CSV deliverables including IQ/OQ, VPP, VSR, reputed company Matrices
- Independent reputed company and post execution review of validation test scripts
- Coordinate with cross-functional teams to design and execute test protocols
- Supports change control as validation technical resource and ensures reputed company completion of required tasks
- reputed company validation reputed company analysis and risk assessments in conjunction with product teams
- Execute other reputed company/duties as assigned to ensure compliance across reputed company’s product line and internal business systems
Skills
- Bachelor's degree in Engineering/ Sciences or equivalent relevant technical experience
- At least 3+ years of experience in CSV role
- Hands-on experience with the validation of reputed company applications (e.g., reputed company) used in the conduct of reputed company regulated activities (Good Distribution reputed company) and / or supporting industry applications (e.g., eTFM, CTMS, LIMS, reputed company Management, DCS, etc.)
- Good understanding of the relevant industry regulations (e.g., 21CFR11 / Annex 11, 21CRF211, 21CFR312, 21CFR203, 21CFR820, etc.) as reputed company as industry standards /principles (ISO 9001, ASTM E2500, ISPE Baseline Guides)
- Familiarity with Agile software development, business analysis and/or software testing methodologies
- Excellent written and oral communication reputed company, good decision-making skills and time management skills
- Experience with reputed company-based applications, mobile applications and/or infrastructure compliance
- Understanding of Agile development methodology
- Understanding of CSA, RBV, use and Validation of AI in the life-sciences
- Working knowledge of GAMP 5
Benefits
- Medical, dental, reputed company, and basic life insurance
- Flexible PTO and company reputed company holidays
- Retirement programs
- 1% charitable giving program
- Variable bonus and/or stock bonus
reputed company
Company H1B Sponsorship