Please response here: Indrara...@simplion.com
Hello,
We are looking for an Sr. QA Lead position in California (Multiple location in CA). Please check the requirement and get back to me with updated resume, Even you can call me back on my number: 408717-4882.
Location: Cypress, Corporate Ave, San Clemente, Calle Batido, San Juan Capistrano, Ortega Hwy, Valencia, Tourney Road, California
Position: Sr. QA Lead
Work authorization: Any
Rate: XX
Position Type: Contract
Interview: Face to Face required
Duration: 12 Months
Start: Immediate
Sr. QA Lead
Required skills:
Software QA/Testing Experience
• Candidate should be having 3 -5 years of experience using Quality Center, QTP and Load Runner tools
• Must be having 7 to 10 years of QA testing experience.
• Must be able to create Testing Strategy, Test Plan, Test cases and Test execution for various kinds of testing’s like system, functional, regression, performance testing.
• Must be having a lead testing experience.
• Must be able to set up defect triage meetings during test execution phase and work with project team from the planning/Analysis phase till implementation phase.
Validation Experience
• Provide validation support for Computer Systems projects within IT, Laboratory and QA departments.
• Apply risk based validation methodologies and deliver services such as validation planning, validation execution, document authoring and validation deliverable tracking.
• Drive risk assessments, analyze data, prepare and review test scripts, qualification protocols, test results, and write validation reports.
• Drive resolution of deviations related to 21 CFR Part 11 compliant systems
• Train other department personnel in specific procedures and validation protocols.
• Coordinate the performance of validation activities with other departments
• Perform document control activities, drive review and approval of validation documents
• Assist the team with migrating towards using automated tools for validation and qualification testing purposes
• Experience working in Life Sciences and Hospital/ Healthcare industries.
• In-depth understanding of computerized systems used in life sciences and Hospital/ Health care industries and intended use.
• Demonstrated understanding of the regulatory requirements (Part 11) and guidance regarding controls over Electronic Record and Electronic Signatures.
• Demonstrated understanding of systems validation regulatory requirements (GxP), regulatory guidance, industry standards ( CLIA , ISO), and other relevant industry best practices (GAMP) .
• Experience in managing Computer Systems Validation projects in a regulated environment.
• Experience auditing software vendors (from a regulated perspective).
• Ability to work in a team-oriented environment establishing and maintaining positive work relationships with co-workers within and across functional areas
• Excellent verbal and written communication skills
• Fluent in English
BS / BA Degree in Computer Science, Engineering related fields, or other life science degree with supplemental technical credentials.
Best Regards,
Indraraj Singh - Lead | SimpliOn - Great Results. Always.
Direct: (408) 717-4882 , Mobile: 240-442-1016 | Fax: 408-935-8696 | Email: indrara...@simplion.com
1525 McCarthy Blvd, Suite 228, Milpitas, CA 95035