We are Hiring
Sr. System Validation Analyst
- 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
IT Project Manager
- DataWarehousing and Business
- Systems/Solutions Architecture through
- All facets of SDL
- Project Management Methodologies
- Enterprise, Architecture, Management
- SOA and EAI(Hub/Spoke and ESB)
- Biotech/Life, Sciences/Pharmaceutical, R&D Domains
- Architecting,Implementing & Supporting global
- GCP, GxP and CFR 21 Part 11
- Data Management
- Technology & Data Integration
- Team Leadership
Software Quality Assurance Engineer
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.
Enterprise Agile Coach