SBA Certified 8(a)

Careers

We are Hiring

Sr. System Validation Analyst
Lead and Manages the system validation function to ensure compliance with applicable regulations. In addition, serves as a system validation expert to support the projects.

  • Review and approve all validation documentations with full responsibility.
  • Review of dozens of validation documents on a weekly basis.
  • Review and approve all validation and testing deliverables for their accuracy and quality.
  • Oversees and provides guidance on test scripts, automates test scripts, and resolves issues encountered during execution of test scripts.
  • Oversee Compliance Operations audit activities so that they are fully aligned with project implementation and validation/testing activities
  • Alignvalidation team with business and IT colleagues to create positive synergy between groups and improve quality
  • Helps to define the validation priorities for IT.
  • Investigates and evaluates new technologies, software, and tools. Submits summaries and makes recommendations to the management.
  • Write and execute IQ/OQ/PQ /UAT /VP and VSR

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IT Project Manager
Strategic focused and business oriented technical professional with 10+ years of progressive experience in InformationTechnology.
CORE STRENGTHS

  • DataWarehousing and Business
  • Intelligence
  • Systems/Solutions Architecture through
  • Deployment
  • All facets of SDL
  • Project Management Methodologies
  • Enterprise, Architecture, Management
  • Frameworks
  • SOA and EAI(Hub/Spoke and ESB)
  • Architectures
  • Biotech/Life, Sciences/Pharmaceutical, R&D Domains
  • Architecting,Implementing & Supporting global
  • Solutions
  • GCP, GxP and CFR 21 Part 11
  • Data Management
  • Technology & Data Integration
  • Team Leadership

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Software Quality Assurance Engineer
Software Quality Assurance Lead/Manager responsible for all aspects of software compliance and for managing a team of software Engineers as part of the roll-out (Agile development methodology) of the new Software & Services Provisioning System-a SaaS cloud-based system

Provided guidance in drafting and approving: system Intended Use & Base Risk Statements (application & interfacing database) , Legacy System Remediation Software /System Assessments (all countries), Legacy System Remediation Electronic Records/Electronic Signatures Assessment, User Requirements Specification, Validation Plan, Functional Requirements Specification, Test Plan, Hazard Risk Analysis, Requirements Traceability Analysis, Installation Verification Test Protocol, Operational Test Protocol, and Final Validation Report. At least five years of experience as SQA. Knowledgeable with agile and waterfall development method.
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Enterprise Agile Coach
We are looking for a Enterprise Agile Coach with at least 5 years of experience
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